(21 days)
The D-VIEW 3MP (X213C3P0E, X213G3P0E) and 2MP (X213C2P0E) LCD Display is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
LCD display is a display system for medical viewing, with high resolution 1600 x 1200(X213C2P0E , X213G2P0E) and 2048 x 1536 (X213C3P0E , X213G3P0E), built-in brightness stabilization circuit, front sensor and ambient light sensor, stable brightness and persistent calibration can be guaranteed. These displays can support both landscape and portrait mode. The anti-reflection coated protective screen can prevent display from damage under hard using conditions, make the clean and disinfect easier.
The provided text describes a 510(k) premarket notification for a medical LCD display, comparing it to a predicate device to demonstrate substantial equivalence. The document does not describe a study that proves the device meets clinical acceptance criteria in the manner requested.
Specifically, the document focuses on technical specifications, regulatory compliance (IEC standards, 21 CFR 1020.33), and a comparison of physical and performance characteristics with a predicate device. It asserts "substantial equivalence" based on these factors, rather than providing clinical performance data or studies against specific acceptance criteria for diagnostic accuracy.
Therefore, many of the requested details, such as sample size for test sets, data provenance, expert qualifications for ground truth, adjudication methods, MRMC studies, standalone performance, and details about training sets, are not present in this document. The device in question is a display, not an AI algorithm or a diagnostic tool that provides an output requiring such validation.
However, I can extract the information related to the acceptance criteria as described in this document, which are primarily technical standards and substantial equivalence to a predicate device.
Acceptance Criteria and Study for D-VIEW LCD Display (K151854)
The "acceptance criteria" for this device, as presented in this 510(k) submission, are primarily based on demonstrating substantial equivalence to a predicate device (BARCO N.V., Coronis 3MP, K131246) and compliance with relevant technical and safety standards. There is no clinical study that "proves the device meets acceptance criteria" in the sense of diagnostic accuracy or clinical outcomes presented here, as the device is a display monitor. The demonstration of equivalence and compliance serves as the proof of meeting regulatory acceptance.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Demonstration of Substantial Equivalence and Compliance) | Reported Device Performance (Proposed Device: D-VIEW 3MP/2MP LCD display) | Basis for "Acceptance" (as per the document) |
|---|---|---|
| Intended Use: Functionally identical to predicate. | "The D-VIEW 3MP and 2MP LCD Display is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners." | "Review of ID 1 - Intended use, both of them are intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners. So the SE is not affected." |
| Technical Characteristics: Comparable to predicate, and compliant with relevant standards (21CFR1020.33). | Panel Size and Type: 21.3", TFT LCD display (same as predicate).Pixel Pitch: 0.2115 × 0.0705mm (3MP), 0.270 × 0.270mm (2MP) (comparable to predicate's 0.2115 mm).Native Resolutions: 1600 x 1200 (2MP), 2048 x 1536 (3MP) (comparable to predicate's 2048 x 1536).Brightness: Varies by model (e.g., 1900cd/m2 for 2MP X213G2P0E, 800cd/m2 for 3MP X213C3P0E), generally comparable or exceeding predicate's 1700 cd/m2.Contrast Ratio: 1400:1 (predicate: 1300:1).Operating Temperature: 0°C ~ 40°C (same as predicate).Storage Temperature: -20°C ~ 60°C (same as predicate).Operating Humidity: 30% ~75%(non-condensing) (comparable to predicate's 8% ~80%). | "All of parameters comply with 21CFR1020.33 and related IEC standards. We did not use any new technology in this system, so those differences between our new system and its predicate do not affect the safety and effectiveness (SE).""Contrast Ratio... 1400:1 is better than 1300:1 in terms of the image quality. Therefore, they can be considered Substantially Equivalent in safety and effectiveness." |
| Safety and EMC Standards Compliance: Adherence to IEC 60601-1, IEC 60601-1-2. | Electrical & Mechanical safety & Thermal safety: Evaluation conducted as per IEC 60601-1.EMC Evaluation: Complying with IEC 60601-1-2. | "Review of ID 8 - Electrical & Mechanical safety& Thermal safety, both are the same, so the SE is not affected.""Review of ID 9 - EMC, both are the same, so the SE is not affected." |
| Biocompatibility: No direct patient contact. | "The proposed device does not contain any components that come into direct or indirect contact with patients, so the evaluation doesn't need to be needed [sic]." | "Review of ID 6 - Biocompatibility, both are the same, so the SE is not affected." |
| Sterility: No sterilization required. | "The proposed device does not need sterilization." | "Review of ID 7 - Sterility, both are the same, so the SE is not affected." |
Detailed breakdown of requested information based on the document's content:
2. Sample size used for the test set and the data provenance:
- Not applicable / Not provided. This document does not describe a clinical test set or data provenance for evaluative performance. The "study" here is primarily a technical comparison and compliance assessment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. Ground truth, in the context of diagnostic accuracy, is not relevant for this type of device (a display monitor) in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. No test set requiring adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This device is an LCD display, not an AI-assisted diagnostic tool. An MRMC study is not relevant to its type or to this 510(k) submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable / No. This is a hardware display device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable / Not provided. As mentioned, ground truth for diagnostic purposes is not relevant for this submission about a display monitor. The "ground truth" equivalent would be established technical standards and the specifications of the predicate device.
8. The sample size for the training set:
- Not applicable / Not provided. This document does not describe a machine learning algorithm or a training set.
9. How the ground truth for the training set was established:
- Not applicable / Not provided. As above, no training set or ground truth in that context is described.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, composed of three overlapping shapes that resemble a person's head, torso, and legs. The figure is oriented to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 28, 2015
D-VIEW Display Technology Co., Ltd. % Mr. Jianfei Sun Regulatory Manager 3F, Building 4, No.12# Kechuang 13th Street, BDA area Beijing 100176 CHINA
Re: K151854 Trade/Device Name: 3MP (X213C3P0E, X213G3P0E) and 2MP (X213C2P0E, X213G2P0E) LCD display Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: July 3, 2015 Received: July 7, 2015
Dear Mr. Sun:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael D'Hara
For
Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K151854
Device Name
3MP (X213C3P0E、X213G3P0E) and 2MP (X213C2P0E、X213G2P0E) LCD display
Indications for Use (Describe)
The D-VIEW 3MP (X213C3P0E, X213G3P0E) and 2MP (X213C2P0E) LCD Display is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
| Prescription Use (Part 21 CFR 201 Subpart D) | Over-The-Counter Use (21 CFR 201 Subpart C) |
|---|---|
| --------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR807.92 (a) (1)]
July 3, 2015
2. Submitter's Information [21 CFR807.92 (a) (1)]
| Name of Sponsor: | D-VIEW Display Technology Co.,Ltd. | |
|---|---|---|
| Address: | 3F, Building 4, No.12# Kechuang 13th Street , BDA area, Beijing, | |
| P.R.China | ||
| Contact Name: | Jianfei Sun | |
| Telephone No.: | +8610 82379533 EXT. 5360 | |
| Fax No.: | +8610 82379511 | |
| Email Address: | sunjianfei@d-view.cn |
3. Trade Name, Common Name, Classification [21 CFR807.92 (a) (2)]
| Trade Name: | D-VIEW |
|---|---|
| Common Name: | 3MP (X213C3P0E X213G3P0E) and 2MP (X213C2P0E X213G2P0E) LCD display |
| Classification: | 892.2050 system, image processing, radiological |
| Product code: | PGY |
| Classification Panel: | Radiology |
| Device Class: | II |
4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]
The identified predicates within this submission are as follows: BARCO N.V., Coronis 3MP(MDCG-3221) has been cleared by FDA through 510(k)
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No.K131246 (Decision Date -May 24, 2013), Classification: 892.2050 system, image processing, radiological Product code: LLZ Device Class: II
5. Description of the Device [21 CFR 807.92(a) (4)]
LCD display is a display system for medical viewing, with high resolution 1600 x 1200(X213C2P0E , X213G2P0E) and 2048 x 1536 (X213C3P0E , X213G3P0E), built-in brightness stabilization circuit, front sensor and ambient light sensor, stable brightness and persistent calibration can be guaranteed. These displays can support both landscape and portrait mode. The anti-reflection coated protective screen can prevent display from damage under hard using conditions, make the clean and disinfect easier.
6. Intended Use [21 CFR 807.92(a)(5)]
The D-VIEW 3MP (X213C3P0E,X213G3P0E) and 2MP (X213C2P0E,X213G2P0E) LCD Display is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
7. Technological Characteristics [21 CFR 807.92(a)(6)]
| Panel | 21.3", TFT monochrome LCD screen, antiglare |
|---|---|
| Brightness (typ.) | 1900cd/m2 (2MP: X213G2P0E)900cd/m2 (2MP: X213C2P0E)1700cd/m2 (3MP: X213G3P0E)800cd/m2 (3MP: X213C3P0E) |
| CR (typ.) | 1400:1 |
| Viewing angle | R/L 176°, U/D 176° Typ. ( CR ≥ 10 ) |
| Pixel Pitch | 0.2115 × 0.0705mm ( 3MP )0.270 × 0.270mm ( 2MP ) |
| Native resolution | 2048 x 1536 (3MP)1600 x 1200 (2MP) |
| Display area | 433(V)mm × 324 mm(H) |
| Compatible video signals | 3MP:640 x 480@60Hz(progressive)2048x1536@60Hz(progressive)2MP: |
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| 640 x 480@60Hz(progressive) | |
|---|---|
| 1600x1200@60Hz(progressive) | |
| Horizontal resolution | 3MP: 2048x1536@60Hz(progressive) |
| 2MP: 1600x1200@60Hz(progressive) | |
| Bandwidth | 3MP: 267MHz |
| 2MP: 162MHz | |
| Aspect ratio | 4:3 |
| Screen size | 21.3" real diagonal |
| Power | 3MP, X213C3P0E: DC12V 3.5A |
| 3MP, X213G3P0E: DC12V 2.2A | |
| 2MP, X213C2P0E: DC12V 3.5A | |
| 2MP, X213G2P0E: DC12V 2.2A | |
| Input signals | DVI-I, DP |
| Digital input | TMDS ( dual ) |
| Dimension | 375 mm (W) x 434mm (H) x 70mm (D) ( without Stand ) |
| 375 mm (W) x 589 mm (H) x 173mm (D) ( with Stand ) | |
| Weight | 7.0±0.3kg ( without Stand ) |
| 10.5kg±0.3kg ( with Stand ) | |
| OperatingAtmosphericPressure | 70kPa ~ 106kPa |
| Operatingtemperature andhumidity: | Temperature: 0℃~40℃ |
| Humidity: 30% ~75% | |
| Storagetemperature andhumidity: | Temperature: -20°C ~ 60°C |
| Humidity: 0% ~90% |
8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]
8.1 Intended uses:
Table 1 Intended Use Comparison
| ID | Comparison Item | Proposed Device | Predicate Device |
|---|---|---|---|
| D-VIEW 3MP (X213C3P0E,X213G3P0E) and 2MP(X213C2P0E, X213G2P0E) | Coronis 3MP(MDCG-3221) |
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| 1 | IntendedUse | The D-VIEW 3MP(X213C3P0E, X213G3P0E)and 2MP (X213C2P0E,X213G2P0E) LCD Display isintended to be used indisplaying and viewing digitalimages (excluding digitalmammography) for review andanalysis by trained medicalpractitioners. | "The Coronis 3MP(MDCG-3221)" is intended tobe used as a tool in displayingand viewing digital images(excluding digitalmammography) for review andanalysis by trained medicalpractitioners. |
|---|---|---|---|
| --- | ----------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
8.2 Comparison table
| ID | ComparisonItem | Proposed DeviceD-VIEW 3MP (X213C3P0E,X213G3P0E) and 2MP(X213C2P0E, X213G2P0E) | Predicate DeviceCoronis 3MP(MDCG-3221) |
|---|---|---|---|
| 2 | Performance | ||
| 2.1 | Panel Size and Type | 21.3", TFT LCD display | 21.3",TFT LCD display |
| 2.2 | Pixel Pitch | 0.2115 × 0.0705mm (3MP)0.270 × 0.270mm(2MP) | 0.2115 mm |
| 2.3 | Available CabinetColors | Black | Black |
| 2.4 | Native Resolutions | 1600 x 1200 (2MP)2048 x 1536 (3MP) | 2048 x1536 |
| 2.5 | Brightness | 1900cd/m2 (2MP,X213G2P0E)900cd/m2 (2MP,X213C2P0E)1700cd/m2 (3MP,X213G3P0E)800cd/m2 (3MP,X213C3P0E) | 1700 cd/m2 |
| 2.6 | Contrast Ratio | 1400:1 | 1300:1 |
| 2.7 | Network Interface | USB(1 Up, 2 Downstream) | USB(1 Up, 2 Downstream) |
| 2.8 | Active Display Size | 433mm × 324 mm | 433.2mm x 324.9mm |
| 3 | Physical Specifications | ||
| 3.1 | Dimensions(Wx Hx D) | 375 mm (W) x 434mm (H) x70mm (D) ( without Stand ) | 375mm x 488mm x 84mm(without Stand) |
| ID | Comparison Item | Proposed DeviceD-VIEW 3MP (X213C3P0E,X213G3P0E) and 2MP(X213C2P0E, X213G2P0E) | Predicate DeviceCoronis 3MP(MDCG-3221) |
| 375 mm (W) x 589 mm (H) x173mm (D) (with Stand) | Portrait:375mm x 620 | ||
| Temperature | |||
| 3.2 | Operating | 0°C ~ 40°C | 0°C ~ 40°C |
| 3.3 | Transport/ Storage | -20°C ~ 60°C | -20°C ~ 60°C |
| Relative humidity | |||
| 3.4 | Operating | 30% ~75%(non-condensing) | 8% ~80%(non-condensing) |
| 3.5 | Transport/ Storage | 0% ~90% | 5% ~95% |
| 4 | Power Supply | ||
| 4.1 | PowerCapacity | <50W | <40W |
| 4.2 | Input Voltage | 3MP, X213C3P0E: DC12V3.5A | |
| 3MP, X213G3P0E: DC12V2.2A | |||
| 2MP, X213C2P0E: DC12V3.5A | |||
| 2MP, X213G2P0E: DC12V2.2A | 100~240v | ||
| Power adapter: | |||
| MDS-150AAS12 B | |||
| Input: 100-240VAC 50-60Hz | |||
| 2.5-1A Output: 12VDC 10A | |||
| 5 | Human factors (operation characteristic) | ||
| 5.1 | Usability | Button operation,LED indicator | Button operation,LED indicator |
| 5.2 | Mode of operation | Continuous operation | Continuous operation |
| 6 | Biocompatibility | ||
| 6.1 | Evaluation | The proposed device does notcontain any components that | The proposed device doesnot contain any components |
| come into direct or indirect | that come into direct or | ||
| contact with patients, so the | indirect contact with patients, | ||
| evaluation doesn't be needed. | so the evaluation doesn't be | ||
| needed. | |||
| 7 | Sterility | ||
| ID | ComparisonItem | Proposed DeviceD-VIEW 3MP (X213C3P0E,X213G3P0E) and 2MP(X213C2P0E, X213G2P0E) | Predicate DeviceCoronis 3MP(MDCG-3221) |
| 7.1 | Sterilization | The proposed device does notneed sterilization. | The proposed device doesnot need sterilization. |
| 8 | Electrical & Mechanical safety& Thermal safety | ||
| 8.1 | Type of protectionagainst electricshock | Class I | Class I |
| 8.2 | Degree of protectionagainst harmfulingress of liquid | Ordinary equipment. | Ordinary equipment. |
| 8.3 | Evaluation | The electrical, mechanical andthermal safety evaluation isconducted as per therequirements of the standardIEC 60601-1. | The electrical, mechanicaland thermal safety evaluationis conducted as per therequirements of the standardIEC 60601-1. |
| 9 | Electromagnetic Compatibility | ||
| 9.1 | EMC Evaluation | Complying withIEC 60601-1-2 | Complying withIEC 60601-1-2 |
Table 2 General Comparison
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8.4 Discussion of Differences:
It is reasonable that there are some differences between our new system and its predicate. All of parameters comply with 21CFR1020.33 and related IEC standards. We did not use any new technology in this system, so those differences between our new system and its predicate do not affect the safety and effectiveness (SE).
Review of ID 1 - Intended use, both of them are intended to be used in displaying and viewing digital images(excluding digital mammography) for review and analysis by trained medical practitioners. So the SE is not affected.
Review of ID 2 - Performance, except the item as below, it is the same, so the SE is not affected.
-
- Contrast Ratio, The proposed device is 1400:1 and the predicate device is 1300:1, but the 1400:1 is better than 1300:1 in terms of the image quality. Therefore, they can be considered Substantially Equivalent in safety and effectiveness. So the SE is not affected.
Review of ID 3 - Physical Specifications, Dimensions and Relative humidity are comparable, so the SE is not affected
- Contrast Ratio, The proposed device is 1400:1 and the predicate device is 1300:1, but the 1400:1 is better than 1300:1 in terms of the image quality. Therefore, they can be considered Substantially Equivalent in safety and effectiveness. So the SE is not affected.
Review of ID 4 - Power Supply, both of them comply with IEC 60601-1 and IEC 510(k) Summary 7-6
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60601-1-2. Therefore, they can be considered Substantially Equivalent in safety and effectiveness. So the SE is not affected.
Review of ID 5 - Human factors, both are the same, so the SE is not affected.
Review of ID 6 - Biocompatibility, both are the same, so the SE is not affected.
Review of ID 7 - Sterility, both are the same, so the SE is not affected.
Review of ID 8 - Electrical & Mechanical safety& Thermal safety, both are the same, so the SE is not affected.
Review of ID 9 - EMC, both are the same, so the SE is not affected.
9. Conclusion [21 CFR 807.92(b) (3)]
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, Shenzhen Beacon Display Technology Co., Ltd concludes that D-VIEW 3MP (X213C3P0E、X213G3P0E) and 2MP (X213C2P0E、X213G2P0E) LCD display is substantially equivalent to predicate devices with regard to safety and effectiveness.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).