(39 days)
The 2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+) is intended to be used in displaying and viewing digital images for review, analysis and diagnosis by trained medical practitioners. It does not support the display of mammography images for diagnosis.
Beacon LCD monitor (G22S+, G22SP+, C22S+, C22SP+) is for viewing medical images other than those of mamography. Its using the latest generation of LED back light panel, with the resolution 1600 x 1200 (landscape), 1200 x 1600 (portrait), built-in brightness stabilization circuit, the monitor can guarantee the stable brightness and persistent calibration throughout its life. The anti-glare screen can prevent display from reflection under highlight conditions, making the image and display clearer. The monitor supports DVI-D, DP and VGA.
Model variations are distinguished by characters. G means the Monochrome monitor, C means the Color monitor, and P means the monitor with an additional glass screen. For example, G22S+ is a monochrome LCD monitor; C22SP+ is a color LCD monitor with the additional glass screen.
The provided text describes a 510(k) premarket notification for a medical display monitor, not an AI/ML-driven device. Therefore, the information typically required to describe acceptance criteria and a study proving an AI/ML device meets those criteria (e.g., sample sizes for test and training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment) is not present in this document.
The document focuses on demonstrating substantial equivalence of the Beacon 2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+) to predicate devices (EIZO RadiForce GX240 and RX250/RX250-AR). This is done by comparing:
- Intended Use: Showing it's identical to the predicate devices (displaying digital images for review, analysis, and diagnosis by trained medical practitioners, excluding mammography).
- Technological Characteristics: Comparing specifications like screen technology, resolution, brightness, contrast ratio, inputs, etc., and explaining that any differences do not affect safety or effectiveness.
- Performance Testing (Bench Tests): These tests are conducted on the device itself to verify its physical display characteristics against established guidelines (AAPM TG18), and not really a study assessing diagnostic performance assisted by AI.
To directly answer your request based on the provided document:
There is no information in this document about:
- A table of acceptance criteria and reported device performance for an AI/ML device. The "Performance Testing" section describes bench tests on the display's physical characteristics, not diagnostic performance metrics for an AI system.
- Sample sizes used for a test set and data provenance: No AI/ML test data or patient data is mentioned. The "test set" here refers to the actual monitor units undergoing bench tests.
- Number of experts used to establish ground truth and qualifications: Not applicable for a display monitor's bench testing.
- Adjudication method for the test set: Not applicable.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not conducted as this is a display monitor, not an AI assistance tool.
- Standalone (algorithm only without human-in-the-loop) performance: Not applicable.
- Type of ground truth used: Not applicable in the context of diagnostic "ground truth" for AI. The "ground truth" for the display itself would be defined by performance standards like DICOM GSDF and TG18 guidelines.
- Sample size for the training set: Not applicable as there is no AI/ML training involved.
- How ground truth for the training set was established: Not applicable.
Summary of Device Performance (from "Performance Testing" section):
The document states that the bench tests performed on the G22S+, G22SP+, C22S+, C22SP+ include:
- Verification of conformance to DICOM GSDF (in accordance with AAPM TG18 guideline).
- Measurement of luminance non-uniformity characteristics (TG18 guideline).
- Measurement of chromaticity non-uniformity characteristics (TG18 guideline).
- Measurement of chromaticity at the center of the display screen at 5%, 50%, and 95% of maximum luminance.
- Visual check for miscellaneous artifacts (TG18 guideline).
- Measurement of spatial resolution (MTF).
- Maximum number allowed for each type of pixel defects/faults.
Reported Device Performance:
The document broadly states: "The test results showed that G22S+, G22SP+, C22S+, C22SP+ are with display characteristics equivalent to those of the predicate device... each of which was determined that it would not affect observer's performance." Specific numerical acceptance criteria and the exact measured values are not provided in this excerpt, only the types of tests performed and the general conclusion of equivalence.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services, which features a stylized human figure. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 27, 2017
Shenzhen Beacon Display Technology Co., Ltd. % Fu Ailing Document Engineer 12F, Block B1, Nanshan Zhiyuan, No.1001 Xueyuan Road Shenzhen Guangdong 518055 CHINA
Re: K172815
Trade/Device Name: 2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: August 29, 2017 Received: September 18, 2017
Dear Fu Ailing:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov
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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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) 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.
Robert Oels
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K172815
Device Name
2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+)
Indications for Use (Describe)
The 2MP LCD Monitor (G22S+, G22S+, C22S+, C22SP+) is intended to be used in displaying and viewing digital images for review, analysis and diagnosis by trained medical practitioners. It does not support the display of mammography images for diagnosis.
Type of Use (Select one or both, as applicable)
V Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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510(k) Summary
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR807.92 (a) (1)]
August 29, 2017
2. Submitter's Information [21 CFR807.92 (a) (1)]
| Name of Sponsor: | Shenzhen Beacon Display Technology Co., Ltd. | |
|---|---|---|
| Address: | 12F, Block B1, Nanshan Zhiyuan, No.1001 Xueyuan Road, NanshanDistrict, Shenzhen, 518055 China | |
| Contact Name: | Fu Ailing | |
| Telephone No.: | +86-0755-33985118-5150 | |
| Fax No.: | +86-0755-26995755 | |
| Email Address: | fuailing@beacon-display.cn |
3. Trade Name, Common Name, Classification [21 CFR807.92 (a) (2)]
Trade Name/Model: 2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+) Common Name: 2MP LCD Monitor Classification Name: Picture archiving and communications system Regulation Number: 21 CFR 892.2050 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: EIZO NANAO Corporation, 2MP Monochrome LCD Monitor, RadiForce GX240 has been cleared by FDA through 510(k) No. K120407 (Decision Date - April 19, 2012).
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EIZO Corporation, 2MP Color LCD Monitor, RadiForce RX250 and RX250-AR has been cleared by FDA through 510(k) No. K160247 (Decision Date - February 23, 2016).
5. Description of the Device [21 CFR 807.92(a) (4)]
Beacon LCD monitor (G22S+, G22SP+, C22S+, C22SP+) is for viewing medical images other than those of mamography. Its using the latest generation of LED back light panel, with the resolution 1600 x 1200 (landscape), 1200 x 1600 (portrait), built-in brightness stabilization circuit, the monitor can guarantee the stable brightness and persistent calibration throughout its life. The anti-glare screen can prevent display from reflection under highlight conditions, making the image and display clearer. The monitor supports DVI-D, DP and VGA.
Model variations are distinguished by characters. G means the Monochrome monitor, C means the Color monitor, and P means the monitor with an additional glass screen. For example, G22S+ is a monochrome LCD monitor; C22SP+ is a color LCD monitor with the additional glass screen.
6. Intended Use [21 CFR 807.92(a)(5)]
The 2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+) is intended to be used in displaying and viewing digital images for review, analysis and diagnosis by trained medical practitioners. It does not support the display of mammography images for diagnosis.
7. Technological Characteristics [21 CFR 807.92(a)(6)]
| Panel | 21.3", TFT, monochrome, LCD screen, anti-glare,hard coating |
|---|---|
| Brightness (Typ.) | 500 cd/m² |
| CR (Typ.) | 1400:1 |
| Viewing angle | R/L 176°, U/D 176° Typ. (CR > 10) |
| Pixel Pitch | (H) 0. 270 × (V) 0.270 mm |
G22S+/G22SP+ Monochrome LCD monitor
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| Native resolution | 1,200 x 1,600 | |
|---|---|---|
| Display area | 324 mm(H) x 432 mm (V) | |
| Aspect ratio | 3:4 | |
| Screen size | 21.3" real diagonal | |
| Power | DC 12 V/6.0 A | |
| Power consumption | Max. 40 W | |
| Input signals | DVI-D, Display Port, VGA | |
| Plug and play | VESA DDC 2B | |
| Dimension | 369 mm (W) x 506 ~ 626 mm (H) x 235 mm (D) (with stand)369 mm (W) x 483 mm (H) x 65 mm (D) (without stand) | |
| Weight | 6.0 kg (without Stand)9.2 kg (with Stand) | |
| Operatingtemperature andhumidity | Temperature: 5°C ~ 35°CHumidity: 15% ~ 85% | |
| Storage temperatureand humidity | Temperature: -20°C ~ 60°CHumidity:10% ~ 90% |
C22S+/C22SP+ Color LCD monitor
| Panel | 21.3", TFT, color, LCD screen, anti-glare, hard coating |
|---|---|
| Brightness (Typ.) | 500 cd/m² |
| CR (Typ.) | 1400:1 |
| Viewing angle | R/L 176°, U/D 176° Typ. (CR > 10) |
| Pixel Pitch | (H) 0. 270 × (V) 0.270 mm |
| Native resolution | 1,200 x 1,600 |
| Display area | 324 mm(H) x 432 mm (V) |
| Aspect ratio | 3:4 |
| Screen size | 21.3" real diagonal |
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| Power | DC 12 V/6.0 A | |
|---|---|---|
| Power consumption | Max. 60 W | |
| Input signals | DVI-D, Display Port, VGA | |
| Plug and play | VESA DDC 2B | |
| Dimension | 369 mm (W) x 506 ~ 626 mm (H) x 235 mm (D) (withstand)369 mm (W) x 483 mm (H) x 65 mm (D) (withoutstand) | |
| Weight | 6.0 kg (without Stand)9.2 kg (with Stand) | |
| Operatingtemperature andhumidity | Temperature: 5°C ~ 35°CHumidity: 15% ~ 85% | |
| Storage temperatureand humidity | Temperature: -20°C ~ 60°CHumidity:10% ~ 90% |
8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]
8.1 Intended uses:
| ID | ComparisonItem | Proposed Device2MP Monochrome LCDMonitor (G22S+, G22SP+) | Predicate Device2MP Monochrome LCDMonitor (RadiForce GX240) |
|---|---|---|---|
| 1 | Intended Use | The 2MP LCD Monitor(G22S+, G22SP+) is intendedto be used in displaying andviewing digital images forreview, analysis and diagnosisby trained medicalpractitioners. It does notsupport the display ofmammography images fordiagnosis. | The RadiForce GX240 isintended to be used in displayingand viewing digital images bytrained medical practitioners. TheRadiForce GX240 does notsupport the display ofmammography images fordiagnosis. |
| Table 1 Intended Use Comparison of G22S+/G22SP+ | |||||
|---|---|---|---|---|---|
| -- | -- | -- | -- | -- | -------------------------------------------------- |
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| ID | Comparison Item | Proposed Device2MP Color LCD Monitor(C22S+, C22SP+) | Predicate Device2MP Color LCD Monitor(RX250, RX250-AR) |
|---|---|---|---|
| 1 | Intended Use | The 2MP LCD Monitor (C22S+,C22SP+) is intended to beused in displaying and viewingdigital images for review,analysis and diagnosis bytrained medical practitioners. Itdoes not support the display ofmammography images fordiagnosis. | This product is intended to beused in displaying and viewingdigital images for review, analysisand diagnosis by trainedmedical practitioners. It does notsupport the display ofmammography images fordiagnosis. |
Table 2 Intended Use Comparison of C22S+/C22SP+
8.2 Comparison table
| ID | ComparisonItem | Proposed Device2MP MonochromeLCD Monitor (G22S+,G22SP+) | Predicate Device2MP MonochromeLCD Monitor(RadiForce GX240) | Explanation ofDifference |
|---|---|---|---|---|
| 2 | Display Performance/Specifications | |||
| 2.1 | ScreenTechnology | Monochrome TFTLCD Panel (IPS) | Monochrome TFTLCD Panel (IPS) | - |
| 2.2 | Viewing angle(H, V) | H: 176°, V: 176° | H: 176°, V: 176° | - |
| 2.3 | Resolution | 2MP (1,200 x 1,600) | 2MP (1,200 x 1,600) | - |
| 2.4 | Aspect ratio | 3 : 4 | 3 : 4 | - |
| 2.5 | Active screensize | 324.0 mm x 432.0 mm | 324.0 mm x 432.0 mm | - |
| 2.6 | Pixel pitch | 0.270 mm x 0.270 mm | 0.270 mm x 0.270 mm | - |
| 2.7 | Typicalluminance | 1900 cd/m² | 1200 cd/m² | Different screen |
| 2.8 | DICOM calibrated luminance | 500 cd/m² | 500 cd/m² | - |
| 2.9 | Contrast ratio | 1400:1 | 1400 : 1 | - |
| 2.10 | Backlighting | LED | LED | - |
| 2.11 | Grayscale Tones | 10-bit (DisplayPort):1,024 from a palette of 16,369 tones8-bit: 256 from a palette of 16,369 tones | 10-bit (DisplayPort):1,024 from a palette of 16,369 tones8-bit: 256 from a palette of 16,369 tones | - |
| 2.12 | Luminance non-uniformity compensation | - | Digital Uniformity Equalizer | Different design scheme |
| 3 | Video Signals | |||
| 3.1 | Input video signals | DVI-D x 1,DisplayPort x 1,VGA x 1 | DVI-D x 1,DisplayPort x 1 | Different design scheme |
| 3.2 | Ouput video signals | - | DisplayPort x 1 (daisy chain) | Different design scheme |
| 3.3 | Scanning Frequency (H, V) | 31 - 100 kHz / 59 - 61 HzFrame synchronous mode: 59 - 61 Hz | 31 - 100 kHz / 59 - 61 HzFrame synchronous mode: 59 - 61 Hz | - |
| 4 | Power Related Specifications | |||
| 4.1 | Power Requirements | DC 12 V/6.0 A | AC 100 -120 V, 200 - 240 V: 50 / 60 Hz | Difference between Built-in power supply and Built-out power supply |
| 4.2 | Power Consumption / Save Mode | 40 W/Less than 5 W | 76 W / Less than 1.6 W | Different design scheme |
| 4.3 | Power Management | DVI DMPM,DisplayPort 1.1a | DVI DMPM,DisplayPort 1.1a | - |
| 5 | Miscellaneous Features/Specifications | |||
| 5.1 | QC software | Beacon MonitorManage | RadiCS | Different designscheme |
| 5.2 | Sensors | G22S+:Backlight Sensor,Ambient Light SensorG22SP+:Backlight Sensor,Ambient Light SensorIntegrated FrontSensor | Backlight Sensor,Presence Sensor,Integrated FrontSensorAmbient LightSensor | Different designscheme |
| 5.3 | USBPorts/Standard | 1 upstream,2 downstream | 1 upstream,2 downstream | - |
| 5.4 | Dimensionsw/o stand (W xH x D) | 369 x 483 x 65 mm | 376 x 505 x 98 mm | Different housingdesign due to thedifferent panelsize |
Table 3 General Comparison of G22S+/G22SP+
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Table 4 General Comparison of C22S+/C22SP+
| ID | ComparisonItem | Proposed Device2MP Color LCDMonitor (C22S+,C22SP+) | Predicate Device2MP Color LCDMonitor(RX250, RX250-AR) | Explanation ofDifference |
|---|---|---|---|---|
| 2 | Display Performance/Specifications | |||
| 2.1 | ScreenTechnology | IPS TFT Color LCDPanel | IPS TFT Color LCDPanel | - |
| 2.2 | Viewing angle(H, V) | H: 176°, V: 176° | H: 176°, V: 176° | - |
| 2.3 | Resolution | 2MP (1,200 x 1,600) | 2MP (1,200 x 1,600) | - |
| 2.4 | Aspect ratio | 3 : 4 | 3 : 4 | - |
| 2.5 | Active screensize | 324.0 mm x 432.0 mm | 324.0 mm x 432.0 mm | - |
| 2.6 | Pixel pitch | 0.270 mm x 0.270 mm | 0.270 mm x 0.270 mm | - |
| 2.7 | Typicalluminance | 900 cd/m² | 800 cd/m² | Different screen |
| 2.8 | DICOMcalibratedluminance | 500 cd/m² | 400 cd/m² | Different screen |
| 2.9 | Contrast ratio | 1400 : 1 | 1400 : 1 | - |
| 2.10 | Backlighting | LED | LED | - |
| 2.11 | Display Colors | From a palette of 68billion colors:- 10-bit input(DisplayPort): 1.07billion colors(maximum)- 8-bit input: 16.77million colors | From a palette of 68billion colors:- 10-bit input(DisplayPort): 1.07billion colors(maximum)- 8-bit input: 16.77million colors | - |
| 2.12 | Luminancenon-uniformitycompensation | - | Digital UniformityEqualizer | Different designscheme |
| 3 | Video Signals | |||
| 3.1 | Input videosignals | DVI-D x 1,DisplayPort x 1,VGA x 1 | DVI-D x 1,DisplayPort x 1 | Different designscheme |
| 3.2 | Ouput videosignals | - | - | - |
| 3.3 | ScanningFrequency (H,V) | 31 - 100 kHz / 59 - 61Hz(VGA Text: 69 - 71 Hz)Frame synchronousmode: 59 - 61 Hz | 31 - 100 kHz / 59 - 61Hz(VGA Text: 69 - 71Hz)Frame synchronousmode: 59 - 61 Hz | - |
| 4 | Power Related Specifications | |||
| 4.1 | PowerRequirements | DC 12 V/6.0 A | AC 100 - 240 V: 50 /60Hz | Differencebetween Built-inpower supplyand Built-outpower supply |
| 4.2 | PowerConsumption /Save Mode | 60 W/Less than 5 W | 79 W / Less than 1.6W | Different designscheme |
| 4.3 | PowerManagement | DVI DMPM,DisplayPort 1.1a | DVI DMPM,DisplayPort 1.1a | - |
| 5 | Miscellaneous Features/Specifications | |||
| 5.1 | QC software | Beacon MonitorManage | RadiCS | Different designscheme. |
| 5.2 | Sensors | C22S+:Backlight Sensor,Ambient Light SensorC22SP+:Backlight Sensor,Ambient Light SensorIntegrated FrontSensor | Backlight Sensor,Presence Sensor | Different designscheme |
| 5.3 | USBPorts/Standard | 1 upstream,2 downstream / Rev.2.0 | 1 upstream,2 downstream / Rev.2.0 | - |
| 5.4 | Dimensionsw/o stand (W xH x D) | 369 x 483 x 65 mm | 361 x 465 x 78 mm | Different housingdesign due to thedifferent panelsize |
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It is clear that the technological characteristics differences discussed above do not affect the safety and the effectiveness of the G22S+, G22SP+, C22S+, C22SP+.
8.3 Performance Testing
The bench tests were performed on G22S+, G22SP+, C22S+, C22SP+ as below.
- Verify the conformance to DICOM GSDF in accordance with Assessment of Display Performance for Medical Imaging Systems by AAPM Task Group 18 (TG18 guideline).
- Measure the luminance non-uniformity characteristics of the display screen in accordance with TG18 guideline.
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- Measure the chromaticity non-uniformity characteristics of the display screen in accordance with TG18 guideline.
- Measure the chromaticity at the center of the display screen at 5%, 50% and 95% of the maximum luminance.
- Visually check the presence or absence of miscellaneous artifacts on the display screen in accordance with TG18 guideline.
- Measure the spatial resolution expressed as modulation transfer function (MTF)
- Maximum number allowed for each type of pixel defects/faults
The test results showed that G22S+, G22SP+, C22S+, C22SP+ are with display characteristics equivalent to those of the predicate device, RadiForce GX240, RadiForce RX250 and RX250-AR except some items, each of which was determined that it would not affect observer's performance.
No animal or clinical testing is needed for G22S+, G22SP+, C22S+, C22SP+.
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:
- The intended use of G22S+, G22SP+, C22S+, C22SP+ is totally same as that of the ● predicate device.
- The technological characteristics differences between G22S+, G22SP+, C22S+, C22SP+ and RadiForce GX240, RadiForce RX250 and RX250-AR do not affect the safety and effectiveness, no new risk is raised.
- Demonstrated by the bench tests, the display characteristics of G22S+, G22SP+, C22S+, C22SP+ are equivalent to those of the predicate device.
§ 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).