(56 days)
HMD3C21S : The 3MP Color LCD Monitor HMD3C21S is indicated for use in displaying radiological images for review, and diagnosis by trained medical practitioners. The display is not intended for mammography.
HMD5G21S : The 5MP Monochrome LCD Monitor HMD5G21S is intended to be used in displaying and viewing medical images for diagnosis by trained medical practified personnel. It is intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.
The LCD monitor employs high-luminance LCD panel, and is designed for medical image display.
This document describes the performance assessment of medical LCD monitors (HMD3C21S and HMD5G21S) for displaying radiological images. It is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving clinical effectiveness of an AI algorithm. Therefore, many of the requested elements typically found in AI/ML medical device evaluations (like sample sizes for training/test sets, expert adjudication, MRMC studies, or specific performance metrics using AI) are not applicable or available in this submission.
The "acceptance criteria" here refers to the performance benchmarks for a medical display, ensuring it meets standards for diagnostic imaging. The "study that proves the device meets the acceptance criteria" refers to the bench testing performed on the monitors.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various physical laboratory measurements performed on the monitors to ensure they meet the display requirements. The acceptance criteria are implicit in the tests performed, aiming for performance comparable to existing medical displays. The reported performance is generally "By reporting [method]" or "Measure the [property]", indicating that these measurements were taken rather than providing specific numerical results for each one. This type of submission focuses on demonstrating that the testing was done according to recognized standards.
Implicit Acceptance Criteria (based on tests performed): The monitors must demonstrate adequate performance across these parameters consistent with established medical display standards (e.g., AAPM-TG18, IEC).
| Measurements | HMD3C21S Performance | HMD5G21S Performance |
|---|---|---|
| a. Spatial resolution | By reporting modulation transfer function. | By reporting modulation transfer function. |
| b. Pixel defects (maximum counts, allowed defect types, and locations) | Maximum number allowed for each type. | Maximum number allowed for each type. |
| c. Artifacts | Crosstalk and Ghost. | Crosstalk and Ghost. |
| d. Temporal response | Measure the rise and fall time constants for 5 – 95% and 40 - 60% luminance transitions. | Measure the rise and fall time constants at several (e.g. every 15 levels) grayscale intervals between 0 and 255. |
| e. Luminance (maximum, minimum, achievable, and recommended) | Measure the maximum, minimum, achievable, and recommended luminance. | Measure the maximum, minimum, achievable, and recommended luminance. |
| f. Conformance to a gray scale-to-luminance function (for example, DICOM GSDF) | Luminance Response by AAPM-TG18. | Luminance Response by AAPM-TG18. |
| g. Luminance at 30° and 45°in diagonal horizontal, and vertical directions at center and four corners | NA | By AAPM TG18. |
| h. Luminance uniformity or Mura test | NA | Luminance uniformity and Chromaticity uniformity by AAPM TG18. |
| i. Stability of luminance and chromaticity response with temperature and time of operation or on-time | NA | By AAPM TG18. |
| j. Spatial noise | NA | By noise power spectrum. |
| k. Reflection coefficient | NA | By specular reflection coefficient and diffuse reflection coefficient. |
| I. Veiling glare or small-spot contrast | NA | By AAPM TG18. |
| m. Color tracking (primary colors and color gamut) | Measure the primary colors and color gamut. | NA, HMD5G21S employs gray scale LCD panel. |
| n. Gray tracking (gray shades and white points) | NA | Measure the maximum chromaticity variation by IEC. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated as a "sample size" in the context of diagnostic performance testing with cases. This submission is for a medical monitor, not an AI diagnostic algorithm. The "testing" refers to the physical bench testing of the device itself.
- Data Provenance: No patient data or clinical images are referenced for the performance testing of the monitor. The testing relates to the physical characteristics and display capabilities of the monitor hardware.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This document is for a medical display device, not an AI algorithm that requires setting ground truth for image interpretation. The "ground truth" for a monitor's performance is established by objective physical measurements against industry standards (e.g., AAPM-TG18).
4. Adjudication method for the test set
- Not Applicable. As no diagnostic performance with images and human readers is being evaluated, no adjudication method is relevant.
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
- Not Applicable. This is a medical monitor, not an AI-powered diagnostic device. No MRMC studies were conducted as part of this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a monitor, not an algorithm. Therefore, standalone performance (in the context of an algorithm's diagnostic output) is irrelevant.
7. The type of ground truth used
- Objective Physical Measurements against Industry Standards. The "ground truth" for a display device is its adherence to performance specifications and established industry standards (e.g., DICOM GSDF, AAPM-TG18), verified through physical and optical measurements using specialized equipment.
8. The sample size for the training set
- Not Applicable. This device is a medical monitor, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI algorithm, no ground truth needed to be established in that context.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Qingdao Hisense Medical Equipment Co., Ltd. % Hanson Chen Official Correspondent Shenzhen Joyantech Consulting Co., Ltd. 1713A,17th Floor, Block A, Zhongguan Times Square, Nanshan District, Shenzhen Shenzhen, Guangdong GD755 CHINA
July 26, 2022
Re: K221567
Trade/Device Name: LCD monitor (HMD3C21S), LCD monitor (HMD5G21S) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: PGY Dated: May 5, 2022 Received: May 31, 2022
Dear Hanson Chen:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica Lamb. Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221567
Device Name
LCD Monitor HMD3C21S, LCD Monitor HMD5G21S.
Indications for Use (Describe) HMD3C21S :
The 3MP Color LCD Monitor HMD3C21S is indicated for use in displaying radiological images for review, and diagnosis by trained medical practitioners. The display is not intended for mammography.
HMD5G218 :
The 5MP Monochrome LCD Monitor HMD5G21S is intended to be used in displaying and viewing medical images for diagnosis by trained medical practified personnel. It is intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Version: A/0
510(k) Summary
1. Contact Details
| 1.1 Applicant information | |
|---|---|
| Applicant Name | Qingdao Hisense Medical Equipment Co., Ltd. |
| Address | No. 399 Songling Road, Laoshan District 266100, Qingdao,Shandong, P. R. China |
| Phone No. | +86-532-83091111 |
| Contact person | Li Mingcheng |
| Contact person's e-mail | limingcheng@hisense.com |
| Date Prepared | May 5, 2022 |
1.2 Submission Correspondent
| Name | Shenzhen Joyantech Consulting Co., Ltd | |
|---|---|---|
| Address | 1713A, 17th Floor, Block A, Zhongguan Times Square, LiuxianAvenue, Xili Town, Nanshan District, Shenzhen, Guangdong,518000, China | |
| Phone No. | +86-755-86069197 | |
| Contact person | Hanson Chen | |
| Contact person's e-mail | hanson@cefda.com | |
| Website | http://www.cefda.com |
2. Device information
| Trade name | LCD monitor |
|---|---|
| Model | HMD3C21S, HMD5G21S |
| Classification | II |
| Classification name | Medical image management and processing system |
| Product code | PGY |
| Regulation No. | 892.2050 |
3. Legally Marketed Predicate Device
| Trade Name | 3MP Color LCD Monitors C32S+, C32SP+, 3MP Monochrome |
|---|---|
| 510(k) Number | K201211 |
| Product Code | PGY |
| Manufacturer | Shenzhen Beacon Display Technology Co., Ltd. |
| Trade Name | 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCDMonitor MS-S500 |
| 510(k) Number | K191137 |
|---|---|
| Product Code | PGY |
| Manufacturer | JVC KENWOOD Corporation |
4. Device Description
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The LCD monitor employs high-luminance LCD panel, and is designed for medical image display.
5. Intended Use/Indication for Use
The 3MP Color LCD Monitor HMD3C21S is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.
The 5MP Monochrome LCD Monitor HMD5G21S is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. It is intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.
6. Substantial Equivalence Comparison
- 6.1 HMD3C21S and its predicate device:
| Elements ofComparison | Subject Device | Predicate Device | Remarks |
|---|---|---|---|
| 510(k) Number | Pending | K201211 | / |
| Manufacturer | Qingdao Hisense MedicalEquipment Co., Ltd | Shenzhen Beacon DisplayTechnology Co., Ltd. | / |
| Devicetype/model | HMD3C21S | 3MP Color LCD MonitorsC32S+, C32SP+ | / |
| Intended use/Indication for use | The 3MP Color LCD MonitorHMD3C21S is indicated foruse in displaying radiologicalimages for review, analysis,and diagnosis by trainedmedical practitioners. Thedisplay is not intended formammography. | The 3MP Color LCD MonitorsC32S+, C32SP+ are indicatedfor use in displaying radiologicalimages for review, analysis, anddiagnosis by trained medicalpractitioners. The displays arenot intended for mammography. | Same |
| Prescription orOTC | RX | RX | Same |
| Electrical Safety | Compliance with IEC 60601-1 | Compliance with IEC 60601-1 | Same |
| EMC | Compliance with IEC 60601-1-2 | Compliance with IEC 60601-1-2 | Same |
| Performancetesting | FDA guidance "Display devices for Dignostic Radiology" | FDA guidance "Display devicesfor Dignostic Radiology" | Same |
| Elements ofComparison | Candidate Device | Predicate Device | Remarks |
| 510(k) Number | Pending | K201211 | / |
| Manufacturer | Qingdao Hisense MedicalEquipment Co., Ltd | Shenzhen BeaconDisplay Technology Co.,Ltd. | / |
| Device type/model | HMD3C21S | 3MP Color LCD MonitorsC32S+, C32SP+ | / |
| Display technology | Color LCD panel (IPS) | Color (IPS) | Same |
| Screen size(Display area) | 540mm/21.3"324.86 x 433.15 mm | 54.1cm/21.3"324.86 x 433.15 mm | Same |
| Backlight type | LED | LED | Same |
| Backlighting | 1000 cd/m² | 1000 cd/m² | Same |
| Frame Rate andRefresh Rate(ScanningFrequency) | 60Hz | 59-61Hz | Same |
| Pixel array(Resolution orMatrix Size) | 1536 x 2048 | 1536 x 2048 | Same |
| Pixel pitch | 0.2115 x 0.2115 mm | 0.2115 x 0.2115 mm | Same |
| Subpixel driving(spatial andtemporal dithering) | NA, no such function. | Not available | / |
| Display interface(Input VideoSignal) | DVI-D x 1,Displayport x 1 | DVI-D x 1,Displayport x 1 | Same |
| Video bandwidth | DVI: 215MHzDisplayPort: 215MHz | DVI: 216MHzDisplayPort: 216MHz | Similar |
| User control | Quality-control softwareThe calibration function | Not available | / |
| Ambient lightsensing | Built-in ambient light sensor | Ambient light sensor | Same |
| Touch-screentechnology | NA, the screen is nottouch-screen. | Not available | / |
| Luminancecalibration tools | Front-facing sensorBody sensorQuality-control software | Integrated opticalsensorExternal optical sensorCalibration software:Beacon MonitorManage | Similar |
| Elements ofComparison | Candidate Device | Predicate Device | Remarks |
| control procedures | Manage | designscheme | |
| Software/Firmware: | |||
| Viewing angle | Horizontal: 178°Vertical: 178° | 178° / 178° | Same |
| Response time(typical) | 25 ms | 25 ms | Same |
| Contrast ratio(typical) | 1500:1 | 1500:1 | Same |
| Display colors | 1073741824 | 1.073 billion | Same |
| Powerrequirements | DC 24V /3.1A | DC 12V /6.67A | Differencebetweenvoltage andelectricity |
| Maximum powerconsumption | 74.4W | 80W | Differencedesignscheme |
| Power save mode | Less than 0.5W | Less than 5W | Differencedesignscheme |
| Sensors | Front-facing sensorBody sensorAmbient light sensor | Backlight sensorIntegrated front sensorAmbient light sensor | Differencedesignscheme |
| USB ports | USB 2.0 x 3 | USB 2.0: Type-B x 1 | Differencedesignscheme |
| Net weight | 10.31 KG | 9.5 KG | Differentweight dueto differentcomponentsand parts |
| VESA standard | 100 x 100mm | 100 x 100mm | Same |
| Dimensions | 366 x 557~677 x 273,366 x 482 x 63 | 369 x 220 x511.5~596.15 | Differenthousingdesign dueto thedifferentpanel size |
| Elements ofComparison | Subject Device | Predicate Device | Remarks |
| 510(k) Number | Pending | K191137 | / |
| Manufacturer | Qingdao Hisense MedicalEquipment Co., Ltd | JVC KENWOOD Corporation | / |
| Devicetype/model | HMD5G21S | MS-S500 | / |
| Intended use/Indication foruse | The 5MP Monochrome LCDMonitor HMD5G21S is intendedto be used in displaying andviewing medical images fordiagnosis by trained medicalpractitioners or certifiedpersonnel. It is intended to beused in digital mammographyPACS, digital breasttomosynthesis and modalitiesincluding FFDM. | MS-S500 is intended to be usedin displaying and viewingmedical images for diagnosis bytrained medical practitioners orcertified personnel.It is intended to be used in digitalmammography PACS, digitalbreast tomosynthesis andmodalities including FFDM. | Same |
| Prescription orОТС | RX | RX | Same |
| ElectricalSafety | Compliance with IEC 60601-1 | Compliance with IEC 60601-1 | Same |
| EMC | Compliance with IEC 60601-1-2 | Compliance with IEC 60601-1-2 | Same |
| Performancetesting | FDA guidance "Display devicesfor Dignostic Radiology" | FDA guidance "Display devicesfor Dignostic Radiology" | Same |
Table 01: General Comparison Table
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Version: A/0
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Version: A/0
6.2 HMD5G21S and its predicate device:
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Version: A/0
Table 03: General Comparison Table
Table 04: Detailed Comparison Table
| Elements ofComparison | Subject Device | Predicate Device | Remarks |
|---|---|---|---|
| 510(k) Number | Pending | K191137 | / |
| Manufacturer | Qingdao Hisense MedicalEquipment Co., Ltd | JVC KENWOODCorporation | / |
| Device type/model | HMD5G21S | MS-S500 | / |
| Display technology | Gray scale LCD panel (IPS) | TFT Monochrome LCDPanel (IPS) | Differencebetween grayandmonochrome |
| Screen Size(Display Area) | Horizontal: 422.4mmVertical: 337.92mm | Horizontal: 337.92mmVertical: 422.4mm | Same |
| Backlight type | LED | LED | Same |
| Elements ofComparison | Subject Device | Predicate Device | Remarks |
| Brightness | 3000 cd/m² | 3000 cd/m² | Same |
| Frame Rate andRefresh Rate(ScanningFrequency) | 50Hz | Portrait:Horizontal:129.1KHzVertical:50HzLandscape:Horizontal:103.5KHzVertical:50Hz | Differencedesignscheme |
| Pixel array(Resolution orMatrix Size) | 2048 x 2560 | 2048 x 2560 | Same |
| Pixel pitch | 0.165 x 0.165 mm | 0.165 x 0.165 mm | Same |
| Subpixel driving(spatial andtemporal dithering) | NA, no such function. | Not available | / |
| Display interface(Input VideoSignal) | DVI-D x 1,Displayport x 1 | DVI-D x 1,Displayport x 1 | Same |
| Video bandwidth | DVI : 215MHzDisplayPort : 215MHz | Not available | / |
| User control | Quality-control softwareThe calibration function | QA Medivisor /Medivisor NX F-CAL | Differencedesignscheme |
| Ambient lightsensing | Built-in ambient light sensor | Built-in ambient lightsensor | Same |
| Touch-screentechnology | NA, the screen is nottouch-screen. | Not available | / |
| Luminancecalibration tools | Built-in calibration sensorQuality control software | Integrated opticalsensorExternal optical sensorCalibration software:Beacon Monitor Manage | Differencedesignscheme |
| Software/Firmware: | |||
| Viewing angle | Horizontal: 178°Vertical: 178° | Horizontal: 178°Vertical: 178° | Same |
| Aspect ratio | 5:4 | 4:5 | Same |
| Response time(typical) | 25 ms | 25 ms | Same |
| Contrast ratio(typical) | 2000:1 | 2000:1 | Same |
| Grayscale tones | 256 gray scales/single | 10-bit (DisplayPort): | Difference |
| Elements ofComparison | Subject Device | Predicate Device | Remarks |
| subpixels (for DP 10-bitinput) | 1,024 from a palette of16,369 tones8-bit (DVI): 256 from apalette of 16,369 tones | designscheme | |
| Powerrequirements | DC 24V, 3.3A | AC 100-240V, 50/60Hz | Differencebetweenbuilt-in powersupply andbuilt-outpower supply |
| Maximum powerconsumption | 79.2W | 80W | Differencedesignscheme |
| Power save mode | Less than 0.5W | Less than 1W | Differencedesignscheme |
| Sensors | Front-facing sensorAmbient light sensor | Front sensorAmbient light sensor | Same |
| USB ports | 1 uplink2 downlink /Rev.2.0 | 1 upstream2 downstream /Rev.2.0 | Same |
| Dimensions | 366 x 495~610 x 58,366 x 496 x 58 | 361 x 517/612 x 196.5 | Differenthousingdesign dueto thedifferentpanel size |
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Version: A/0
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Version: A/0
7. Performance Testing-Bench
The recommended physical laboratory tests were performed on the proposed devices HMD3C21S and HMD5G21S.
| Measurements | HMD3C21S | HMD5G21S |
|---|---|---|
| a. Spatial resolution | By reporting modulationtransfer function. | By reporting modulation transferfunction. |
| b. Pixel defects (maximum counts,allowed defect types, and locations) | Maximum numberallowed for each type. | Maximum number allowed foreach type. |
| c. Artifacts | Crosstalk and Ghost. | Crosstalk and Ghost. |
| d. Temporal response | Measure the rise and falltime constants for 5 –95% and 40 - 60%luminance transitions. | Measure the rise and fall timeconstants at several (e.g. every15 levels) grayscale intervalsbetween 0 and 255. |
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Qingdao Hisense Medical Equipment Co., Ltd.
| Product: LCD monitor | |
|---|---|
| ---------------------- | -- |
Version: A/0
| e. Luminance (maximum, minimum, achievable, and recommended) | Measure the maximum, minimum, achievable, and recommended luminance. | Measure the maximum, minimum, achievable, and recommended luminance. |
|---|---|---|
| f. Conformance to a gray scale-to-luminance function (for example, DICOM GSDF) | Luminance Response by AAPM-TG18. | Luminance Response by AAPM-TG18. |
| g. Luminance at 30° and 45°in diagonal horizontal, and vertical directions at center and four corners | NA | By AAPM TG18. |
| h. Luminance uniformity or Mura test | NA | Luminance uniformity and Chromaticity uniformity by AAPM TG18. |
| i. Stability of luminance and chromaticity response with temperature and time of operation or on-time | NA | By AAPM TG18. |
| j. Spatial noise | NA | By noise power spectrum. |
| k. Reflection coefficient | NA | By specular reflection coefficient and diffuse reflection coefficient. |
| I. Veiling glare or small-spot contrast | NA | By AAPM TG18. |
| m. Color tracking (primary colors and color gamut) | Measure the primary colors and color gamut. | NA, HMD5G21S employs gray scale LCD panel. |
| n. Gray tracking (gray shades and white points) | NA | Measure the maximum chromaticity variation by IEC |
8. Clinical testing
Not applicable.
-
- Other information (such as required by FDA guidance/Test) Not applicable.
10. Conclusions Drawn from Non-Clinical and Clinical Tests
The LCD monitor is substantially equivalent to the legally marketed predicate device 3MP Color LCD Monitors C32S+, C32SP+ (K201211) and 5MP Monochrome LCD Monitor MS-S500 (K191137).
§ 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).