技術資料(医療機関・PACSベンダー向け)

DICOM準拠声明(DICOM Conformance Statement)

スマぞう端末が、貴院で発行している検査画像ディスク(CD/DVD)をどのように読み取るかを、DICOM規格 PS3.2 の様式に沿って記載した技術文書です。対応する転送構文(Transfer Syntax)・文字集合・読み取りの制限事項・プレビュー画像の仕様を記載しています。PACSやメディア出力装置のベンダー様との互換性確認にご利用ください。

  • 言語英語のみ(DICOM準拠声明の国際的な慣行に合わせています)
  • 文書版1.0(2026-09-14)
  • 対象スマぞう端末(可搬媒体の読み取り=File-Set Reader)。スマートフォンアプリはDICOMを解釈しないため対象外です

スマぞうは医療機器ではありません。本文書は技術的な互換性の情報であり、転送・表示される画像は診断用途にはご利用いただけません。

sumazou Terminal — DICOM Conformance Statement

ItemValue
Productsumazou terminal (medical-image DVD/CD → smartphone transfer kiosk)
Software versionTerminal software v1.1.0
Document version1.0
Date2026-09-14
Issuerpafin Inc.
StandardStructured after DICOM PS3.2 (Conformance). References: PS3.3, PS3.5, PS3.6, PS3.10, PS3.11, PS3.12
Publicationhttps://sumazou.com/docs/dicom-conformance-statement.html

0. Scope

The product implements no DICOM network services. It is a Media Storage Application that acts solely as a File-Set Reader (FSR) for interchange media (CD/DVD). The PS3.2 "Network AE Specification" sections are therefore not applicable, and the "Media Interchange AE Specification" is the core of this document.

EntityDICOM roleConformance statement
sumazou terminal (this document)Media Storage Application / File-Set Reader (FSR)This document
sumazou app (iOS / Android)Not a DICOM application. It displays terminal-generated preview images and stores / exports the original DICOM files as opaque files. It performs no DICOM parsing, pixel decoding, networking, or media creation.Out of scope
Transfer package (terminal → app)Proprietary format outside the DICOM standard (contains the original DICOM files unmodified)Out of scope (§6)

1. Conformance overview

1.1 Network services

Not applicable. No DIMSE services (C-STORE / C-FIND / C-MOVE / C-GET / C-ECHO), no DICOMweb (WADO-RS / QIDO-RS / STOW-RS), no WADO-URI, no JPIP. Production terminals run fully offline (no hospital LAN, no internet).

The communication between the terminal and the patient's smartphone is a proprietary protocol unrelated to DICOM and is not a DICOM Application Entity.

1.2 Media interchange

ItemValue
RoleFile-Set Reader (FSR) only. No File-Set Creator (FSC) or File-Set Updater (FSU); the terminal never writes to media
Application ProfilesGeneral-purpose profiles (STD-GEN-CD, STD-GEN-DVD-RAM, STD-GEN-DVD-JPEG, STD-GEN-DVD-J2K, …) and IHE PDI (Portable Data for Imaging) media are the intended input. Profile-specific constraints are not enforced: any medium that meets §3.2 is read
Physical media / file systemsCD-R/RW, DVD±R/RW, DVD-RAM readable by a standard optical drive. File systems: ISO 9660 (with Joliet) and UDF

2. Implementation model

2.1 Application data flow

 [Patient inserts a DVD/CD]
        │
        ▼
 ┌────────────────────────────────────────────────────────────────┐
 │ sumazou terminal (Media Import AE = File-Set Reader)           │
 │  1. Read the medium (read-only)                                │
 │  2. Identify the DICOM Part 10 files on it                     │
 │  3. Group them into study / series / instance                  │
 │  4. Copy each original file unmodified into a transfer package │
 │     and render a preview image for image objects               │
 │  5. Transfer the package to the patient's smartphone           │
 │  6. Delete all temporary data                                  │
 └────────────────────────────────────────────────────────────────┘
        │
        ▼
 [Patient's smartphone] (receives, stores, displays)

2.2 Application Entity

The product has exactly one AE and no AE Title (no network presence).

AEFunction
Media Import AEReads a DICOM File-set from interchange media (FSR) and builds a transfer package for the patient's own smartphone. It never writes to media, never communicates over DICOM networks, and never updates the DICOMDIR

2.3 Sequencing

One session handles one medium and transfers to exactly one smartphone, paired via a confirmation code. If the patient cancels or removes the disc during reading, processing stops and the temporary data is deleted.


3. Media Interchange AE specification

3.1 Role

File-Set Reader (FSR) only.

3.2 Requirements on the medium

ItemRequirement
DICOMDIRRequired at the root of the medium (file name DICOMDIR, case-insensitive). A medium without it is rejected as unsupported and ejected
DICOM filesPart 10 files anywhere on the medium are read. A file is recognised as DICOM by the DICM preamble marker or by a .dcm extension (case-insensitive)
Other filesViewer software, AUTORUN.INF, HTML and other non-DICOM files are ignored and do not affect acceptance
Required elementsEvery DICOM file must carry Study Instance UID and Series Instance UID. A medium containing a file without either is rejected
Malformed filesA medium containing a file that is recognised as DICOM but cannot be parsed is rejected

The DICOMDIR is used as the marker of a DICOM medium; grouping into studies, series and instances is derived from the files themselves, so a medium remains readable even when its DICOMDIR records are incomplete.

3.3 SOP Classes

Inclusion in the transfer package does not depend on the SOP Class: every DICOM file on the medium is transferred unmodified, including private SOP Classes.

CategoryTransferredPreview image
Image SOP Classes (CT, MR, CR, DX, MG, US, US Multi-frame, XA, RF, NM, PT, SC, Enhanced family, RT Image, RT Dose, … — anything with Pixel Data)YesYes (§4)
Non-image SOP Classes (SR, Key Object Selection, Presentation State, RT Structure Set, Encapsulated PDF, Waveform, …)YesNo
Objects whose pixel data cannot be decoded (unsupported transfer syntax, non-conforming or corrupt pixel data)YesNo

There is no restriction on Modality (0008,0060).

3.4 Transfer Syntaxes

Header parsing (grouping and inclusion in the package) works for every standard transfer syntax. The table below states whether a preview image can be rendered from the pixel data. "Verified" means confirmed with test media on a production terminal.

Transfer SyntaxUIDPreview
Implicit VR Little Endian1.2.840.10008.1.2Verified
Explicit VR Little Endian1.2.840.10008.1.2.1Verified
Deflated Explicit VR Little Endian1.2.840.10008.1.2.1.99Verified
Explicit VR Big Endian (retired)1.2.840.10008.1.2.2Verified
JPEG Baseline (Process 1), 8-bit1.2.840.10008.1.2.4.50Verified
JPEG Extended (Process 2 & 4), 12-bit1.2.840.10008.1.2.4.51Verified
JPEG Lossless, Non-Hierarchical (Process 14)1.2.840.10008.1.2.4.57Supported
JPEG Lossless, Non-Hierarchical, First-Order Prediction (Process 14 SV1)1.2.840.10008.1.2.4.70Verified
JPEG-LS Lossless1.2.840.10008.1.2.4.80Verified
JPEG-LS Lossy (Near-Lossless)1.2.840.10008.1.2.4.81Supported
JPEG 2000 Image Compression (Lossless Only)1.2.840.10008.1.2.4.90Verified
JPEG 2000 Image Compression1.2.840.10008.1.2.4.91Verified
JPEG 2000 Part 2 Multi-component (Lossless / Lossy)1.2.840.10008.1.2.4.92 / .93No
High-Throughput JPEG 2000 (Lossless / Lossless RPCL / Lossy)1.2.840.10008.1.2.4.201 / .202 / .203Supported
RLE Lossless1.2.840.10008.1.2.5Verified
JPIP Referenced / JPIP Referenced Deflate1.2.840.10008.1.2.4.94 / .95No
MPEG-2 / MPEG-4 AVC / HEVC video family1.2.840.10008.1.2.4.100 – .108No
Other (encrypted, Encapsulated Uncompressed, …)—No

Files in a transfer syntax marked "No" are still transferred unmodified. No transfer-syntax conversion (transcoding) is performed.

3.5 Character sets

Specific Character Set (0008,0005) is honoured for all repertoires defined in PS3.3, including the combinations common on Japanese media:

Specific Character SetStatus
(absent = default repertoire), ISO_IR 100 (Latin-1)Verified
ISO_IR 192 (UTF-8)Verified
ISO 2022 IR 6\ISO 2022 IR 87 (ASCII + JIS X 0208 kanji)Verified
ISO 2022 IR 13\ISO 2022 IR 87 (half-width katakana + JIS X 0208 kanji)Verified
Combinations including ISO 2022 IR 159 (JIS X 0212)Supported

For Patient's Name (0010,0010) the ideographic (kanji) component is used for display on the smartphone when present, otherwise the alphabetic component. Patient identifiers are never shown on the terminal screen (§5).

3.6 Attributes used

PurposeAttributes
Grouping and orderingStudy Instance UID, Series Instance UID, SOP Instance UID, Study Date, Series Number, Instance Number
Display labels (smartphone only)Patient's Name, Institution Name, Study Description, Series Description, Modality
Preview renderingThe Image Pixel, Modality LUT, VOI LUT and Palette Color LUT modules as defined in PS3.3

Missing Instance Number / Series Number are ordered as 0; a missing Study Date is treated as empty.

3.7 Limits

Media exceeding any of the following are rejected as a whole.

ItemLimit
Size of one DICOM file512 MiB
Pixels per frame (Rows × Columns × Samples per Pixel)64,000,000
Instances per medium20,000
Studies per medium100
Series per medium1,000

These limits are fixed and cannot be changed at the installation site.


4. Preview images (format conversion)

Preview images are a format-conversion output for viewing and storing on a smartphone. Diagnostic image quality and grayscale fidelity are not guaranteed.

ItemBehaviour
FrameFirst frame only (multi-frame objects are previewed by frame 1)
Photometric InterpretationMONOCHROME1, MONOCHROME2, RGB, YBR_FULL, YBR_FULL_422, YBR_RCT, YBR_ICT, PALETTE COLOR. Others yield no preview
Grayscale renderingModality LUT and VOI LUT of the object are applied, then the image is converted to 8-bit for display
Overlay / Curve / Presentation State / Icon ImageNot applied
Size and formatJPEG, long edge at most 2048 px (never upscaled), aspect ratio preserved
NoticeEvery preview large enough to carry it has the notice "閲覧用(診断利用不可) by sumazou" ("for viewing — not for diagnostic use") burned in
On failureNo preview; the original DICOM file is still transferred

5. Security and privacy behaviour

  • Media are read read-only; software on the medium is never executed.
  • Patient's Name, Patient ID and Patient's Birth Date never appear on the terminal screen or in terminal logs. Patient ID and Birth Date are not written to the transfer package.
  • UIDs inside the original DICOM files are unchanged. The package metadata carries them only in hashed form.
  • All temporary data of a session (the medium image and the package) is deleted when the transfer completes, on any error, and at every start-up.
  • Media containing more than one patient are transferred normally; the smartphone lists studies by patient name.

6. Terminal output (outside the DICOM standard — reference information)

  • Every original DICOM file is transferred to the smartphone byte-for-byte unmodified: no transfer-syntax conversion, no attribute addition / removal / de-identification, no regeneration of the Part 10 header. A per-file SHA-256 accompanies the package so the smartphone can verify integrity.
  • The smartphone app does not interpret DICOM. The patient can export the original files as-is to other apps or storage (this is not media creation, i.e. not an FSC).

7. Verification

The transfer-syntax, character-set and non-image behaviour in this document is verified by an automated regression suite that runs on every software change, and by reading a coverage disc (CD-R with one series per transfer syntax, photometric interpretation and edge case) on a production terminal.


8. Not supported

  • All DICOM network services (DIMSE, DICOMweb, WADO, JPIP)
  • Media creation or update (FSC / FSU); DICOMDIR generation or update
  • Media-level security (PS3.15 Media Security) or media protected with Encapsulated CMS
  • Transfer-syntax conversion, attribute editing / de-identification, Part 10 header regeneration
  • Previews of frames other than the first; decoding of video transfer syntaxes
  • Rendering of Overlay / Curve / Presentation State / Structured Display
  • Measurement, annotation, WW/WL manipulation, MPR, 3D and similar image processing (deliberately not implemented: the product is not a medical device)
  • Semantic interpretation of private attributes and private SOP Classes (transferred as opaque bytes)

9. Extensions / specialisations / privatisations

None. No private SOP Classes, private transfer syntaxes or private attributes are defined.


10. Configuration

No site-configurable settings affect DICOM reading.