21.3 inch Monochrome Digital Mammography 5M pixel LCD Monitor with sub-pixel driving techniques enabling 15M subpixels to be driven independently, MS55i2 (ML21055, MD211G5) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is to be used in digital mammography PACS and modalities including FFDM.

Device Description

MS55i2 (ML21055, MD211G5) is a 21.3-inch monochrome LCD monitor whose display resolution is 2048 x 2560 (landscape), 2560 x 2048 (portrait) supporting DVI (digital visual interface) and DisplayPort.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the JVCKENWOOD MS55i2 monitor.

The document describes a 510(k) premarket notification for a medical display monitor. The "study" in this context refers to product verification and validation testing to ensure the monitor meets specified technical performance criteria, rather than a clinical study involving human readers or patient outcomes, as is common for AI-powered diagnostic devices.

Here's the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Metric	Acceptance Criteria	Reported Device Performance (as stated or implied)
Display Characteristics
Screen Size (Active)	Not explicitly stated as "acceptance criteria," but specified in both versions.	Horizontal: 337.92mm, Vertical: 422.4mm (for landscape, opposite for portrait). Actual measured: 422.35mm(H) x 337.95mm(V)
Pixel Pitch	Not explicitly stated as "acceptance criteria," but specified.	0.055mm(H) (sub-pixel pitch) x 0.165mm(V) at landscape display. 0.165mm(H) x 0.055mm(V) (sub-pixel pitch) at portrait display.
Maximum Display Resolution	2048 x 2560 dots	2048 x 2560 dots
Input Signal	DVI, DisplayPort	DVI, DisplayPort
Grayscale	Not explicitly stated as "acceptance criteria," but specified.	10.3 bit (1276 gradation)
Luminance
Maximum Luminance (Calibrated)	(Predicate: Min. 850 cd/m² Typ. 1100 cd/m², Calibrated 500 cd/m²)	Min. 850 cd/m² Typ. 1200 cd/m² (as LCD component), (Calibrated 500 cd/m²) - Improvement noted
Max Achievable Luminance	[SPEC] Luminance Max (L.max) = 1200 cd/m²	Spec stated as target. "Refer to actual luminance response data" for confirmation.
Min Achievable Luminance	[SPEC] Luminance Min (Lmin) = 0.5 cd/m²	Spec stated as target. "Refer to actual luminance response data" for confirmation.
Max Recommended (Operational) Luminance	[SPEC] Luminance Max recommend: Lmax(r) = 500 cd/m²	Spec stated as target. "Refer to actual luminance response data" for confirmation.
Min Recommended (Operational) Luminance	[SPEC] Lmin(r) = 0.8 cd/m²	Spec stated as target. "Refer to actual luminance response data" for confirmation.
Luminance Calibration Software	Medivisor (Software), Chroma5 (X-Rite) (Sensor)	Medivisor (Software), Chroma5 (X-Rite) (Sensor)
Contrast
Contrast Ratio	(Predicate: Min. 600 Typ. 850)	Min. 900 Typ. 1200 - Improvement noted
Viewing Angle	(Predicate: CR>20 Typ. 85 deg)	CR>50 Typ. 176 horizontal/vertical - Improvement noted
Grayscale Response (DICOM GSDF Conformance)
Intrinsic Bit-Depth	[SPEC] 8bit per each subpixel	Spec stated as target. "Refer to actual luminance response data" for confirmation.
True Output Bit-Depth	[SPEC] 10.3bit gray scale (1276 steps) achieved by 11bit LUT (Look-up Table) in the Display hardware	Spec stated as target. "Refer to actual luminance response data" for confirmation.
Intrinsic Luminance Response (dJND per dP)	[SPEC] dJND per dP < 3.000, dJNDs/dP max error < 2.000, JNDs/dP RMS error < 1.000 (Based on AAPM-TG18 Advanced Luminance Response 4.3.5)	Spec stated as target. "Refer to actual luminance response data" for confirmation.
Conformance to DICOM GSDF	[SPEC] Kσ within +/- 10% deviation to DICOM GSDF based on AAPM-TG18 Luminance Response 4.3.4	Spec stated as target. "Refer to actual luminance response data including angular dependence" for confirmation.
Image Quality & Physical Characteristics
Angular Dependency of Luminance	[SPEC] C1 R=175, K*=30%	Spec stated as target. "Refer to actual luminance response data including angular dependence" for confirmation.
Luminance Uniformity	[SPEC] Less than 30% based on AAPM-TG18 4.4	Spec stated as target. "Refer to actual luminance uniformity data" for confirmation.
Geometrical Distortion	[SPEC] Less than 2.0% based on A.APM-TG18	Spec stated as target. "Refer to actual Geometrical Distortion data" for confirmation.
Reflectance	[SPEC] Refer to Max allowable ambient luminance in Tables 4 and 5 on AAPM-TG18 4.2.4	Spec stated as target. "Refer to actual Reflectance Data" for confirmation.
Pixel Fill Factor	[SPEC] 30% Min.	Spec stated as target. "Refer to Data of Pixel fill factor." for confirmation.
Noise (RMS / Jitter)	[SPEC] < 0.1 Max at 0.6Hz, 3Hz, 30Hz Jitter	Spec stated as target. "Refer to actual data" for confirmation.
Veiling Glare Ratio (GR)	[SPEC] GR < 400 (based on AAPM-TG18 4.7.4)	Spec stated as target. "Refer to actual veiling glare ratio data" for confirmation.
Chromaticity (Delta u', v')	[SPEC] Delta (u', v') ≤ 0.01 measured at 80% Lmax based on AAPM-TG18 4.8.4	Spec stated as target. "Refer to Chromaticity actual data" for confirmation.
Artifacts (Pixel dropouts, ringing, ghosting, etc.)	[SPEC] Class (pixel) II (ISO13406-2). No ringing, ghosting, image sticking (by visible check)	Spec stated as target. "Refer to table 3 on 3.4.13 ISO13406-2" for pixel dropouts. "By visible check, no ringing, ghosting image sticking" is the reported method.
Spatial Resolution, MTF	Not explicitly quantified as a "SPEC" in the snippets provided.	"Refer to actual MH data" for confirmation.
Temporal Response (Rise Time, Fall Time)	[SPEC] Rise Time Tr. Fall Time F. Tr. Fessons. (Likely an abbreviation for specific numerical thresholds)	Spec stated as target. "Refer to actual data" for confirmation.
Stability (Luminance response via temperature stress)	[SPEC] Kσ within +/- 10% deviation to DICOM GSDF, based on AAPM-TG18 Luminance Response 4.3.4 via temperature stress (0 degC, 25degC, 40degC)	Spec stated as target. "Refer to actual measured data" for confirmation.
Safety Standard	UL60601-1, CSA C22.2 No. 601-1, FCC-B, VCCI-B, MDD/CE.	UL60601-1, CSA C22.2 No. 601-1, FCC-B, VCCI-B, MDD/CE.

Study Details:

The provided document describes physical and performance testing of a medical display monitor against established industry standards and specifications, rather than a clinical study.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: This information is not explicitly provided. For device verification and validation of a monitor, it would typically involve testing of a representative sample of units (e.g., a few units from a production batch or prototypes) to ensure consistency and compliance with specifications. The document repeatedly says "Refer to actual data" for various metrics, indicating that tests were performed, but the number of devices or iterations tested is not stated.
Data Provenance: The device manufacturer, JVC KENWOOD Corporation, is located in Yokohama-shi, Kanagawa, Japan. The testing was conducted internally or by a contracted lab to verify the monitor's technical specifications. This is a retrospective testing of the device's technical performance against established engineering and quality standards rather than a prospective clinical data collection.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This is not applicable as the "ground truth" for a medical display monitor's performance is established by technical standards and specifications (e.g., AAPM-TG18, ISO13406-2, DICOM GSDF), not by expert consensus on clinical images. The "ground truth" refers to the target values or acceptable ranges for physical characteristics like luminance, contrast, uniformity, etc., as defined by these standards.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies where multiple human readers interpret medical images and their opinions need to be reconciled for a ground truth. For a device like a monitor, performance is measured against objective, quantitative technical specifications using calibrated measuring equipment.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study assesses the clinical impact of an AI algorithm on human reader performance when interpreting medical cases. The JVCKENWOOD monitor is a display device, not an AI algorithm. Its performance is evaluated based on its ability to accurately render images according to technical standards.

6. If a Standalone (i.e., algorithm-only without human-in-the-loop performance) Was Done

Yes, in essence. The "study" described is a standalone technical performance evaluation of the monitor itself (the "device-only" performance) against physical and display quality specifications. It measures inherent characteristics of the monitor (e.g., luminance, contrast, uniformity, grayscale response, etc.) without human interaction to "interpret" or diagnose. The device's ability to meet these technical specifications is its "standalone performance."

7. The Type of Ground Truth Used

The ground truth used is primarily technical specifications and established industry standards. Specifically, references are made to:
- AAPM-TG18 (American Association of Physicists in Medicine Task Group 18): For luminance response, luminance uniformity, geometrical distortion, reflectance, veiling glare, chromaticity, and stability.
- DICOM GSDF (Grayscale Standard Display Function): For grayscale conformance.
- ISO13406-2: For pixel dropouts and pixel fill factor.
- Manufacturer's own internal specifications for other characteristics (e.g., maximum luminance, contrast ratio, viewing angle, noise).
- Safety standards like UL60601-1, CSA C22.2 No. 601-1, FCC-B, VCCI-B, MDD/CE.

8. The Sample Size for the Training Set

This is not applicable. Training sets are relevant for machine learning or AI algorithms. This document describes the validation of a hardware device (a monitor), which does not involve a training set.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reason as #8.

Summary

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131137 2

JVCKENWOOD

JUL 1 8 2013

510(k) SUMMARY

Submitted Information:	JVC KENWOOD Corporation3-12, Moriya-cho, Kanagawa-ku, Yokohama-shi,Kanagawa, 221-0022 Japan
Contact Person:	Tsukasa Tashiro, General ManagerEmail: tashiro.tsukasa@jvckenwood.comTel: +81.258.24.6611Fax: +81.258.24.6617
Date Prepared:	July 17, 2013
Device Name:	21.3 inch Monochrome Digital Mammography LCD Monitor MS55i2(ML21055, MD211G5)
Common Name:	MS55i2, ML21055, MD211G5
Classification Name:	Class II(Part 892 Radiology DevicesSec. 892.2050 Picture Archiving and Communication System)
Predicate Device:	21.3 inch (54 cm) Monochrome Digital Mammography LCD MonitorMS53i2 (ML21053) (K111496).
Device Description:	MS55i2 (ML21055, MD211G5) is a 21.3-inch monochrome LCDmonitor whose display resolution is 2048 x 2560 (landscape), 2560 x2048 (portrait) supporting DVI (digital visual interface)andDisplayPort.
Intended Use:	21.3 inch Monochrome Digital Mammography 5M pixel LCD Monitorwith sub-pixel driving techniques enabling 15M subpixels to be drivenindependently, MS55i2 (ML21055, MD211G5) is intended to be used indisplaying and viewing medical images for diagnosis by trained medicalpractitioners. It is to be used in digital mammography PACS andmodalities including FFDM.
Substantial Equivalence:	MS55i2 (ML21055, MD211G5) shares the same characteristics with ourpredicate device MS53i2 (ML21053) (K111496) except for the mainboard, LCD panel and power supply.

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510(k) Number	5M Monochrome Digital MammographyLCD Monitor MS53i2 (ML21053) (K111496)Conventional LCD Panel (IAQS80P)	5M Monochrome Digital MammographyLCD Monitor MS55i2 (ML21055, MD211G5)New LCD Panel (TX54D84MM0BAA)
Display Area	K061447Horizontal: 337.9mm, Vertical: 422.4mm	Not KnownHorizontal: 337.92mm, Vertical: 422.4mm
Input Signal	DVI, DisplayPort	DVI, DisplayPort
Maximum Display	2048 x 2560 dots	2048 x 2560 dots
Scanning Frequency	Horizontal: 129.6K, Vertical: 50Hz - PortraitHorizontal: 103.93KHz, Vertical: 50Hz - Landscape	Horizontal: 129.6K, Vertical: 50Hz - PortraitHorizontal: 103.5KHz, Vertical: 50Hz - Landscape
Maximum Image Clock	148 MHz	285 MHz
Maximum Luminance(Calibrated Luminance)	Min.850 cd/m² Typ.1100cd/m²(500 cd/m² - calibrated luminance)	Min.850 cd/m² Typ.1200cd/m² (as LCD component)(500 cd/m² - calibrated luminance)
Contrast Ratio	Min.600 Typ.850	Min.900 Typ. 1200
Viewing Angle	CR>20 Typ.85deg	CR>50 Typ.176 horizontal/vertical
Luminance Calibration(Optional)	Software (Standard): MedivisorCalibration Sensor (Optional): Chroma5 (X-Rite)	Software (Standard): MedivisorCalibration Sensor (Optional): Chroma5 (X-Rite)
Serial Communication	USB: Downstream port x 2, Upstream port x 1	USB: Downstream port x 2, Upstream port x 1
Grayscale	10.3 bit (1276 gradation)	10.3 bit (1276 gradation)
Safety Standard	UL60601-1, CSA C22.2 No. 601-1, FCC-B, VCCI-B, MDD/CE,	UL60601-1, CSA C22.2 No. 601-1, FCC-B, VCCI-B, MDD/CE,
Weight & Dimension	Net: 12.1kg474.5(W) x 480(H) x 220(D) mm (Landscape)389(w) x 522(H) x 220(D) mm (Portrait)Packed: 17.0 Kg470(W) x 685 (H) x 345(D)	Net: approx. 12.8kg474.5(W) x 480(H) x 220(D) mm (Landscape)390(w) x 522(H) x 220(D) mm (Portrait)Packed: approx.16.0 Kg470(W) x 685 (H) x 345(D)
Power Supply	AC100-240V, 1.5-0.6A, 50/60Hz	AC100-240V, 1.5-0.6A, 50/60Hz

Similarities :
MS55i2 (ML21055) employs the same diver board, tilt stand, power supply, etc. except of those of LCD Panel (included inverter board
Differences: Differences:

ellinentees.
MS55i2 (ML21055) employs a different LCD backlight) and the Maximum Luminance, contrast ratio and viewing angle have been
improved. MD211G5 is the same as MS55

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Display System Description
1. Active-Matrix Liquid-Crystal Displays (AMLCD) panel manufacturer, technology Screen size andpixel pitch:
	Screen size: 422.4mm(H) x 337.92mm(V) at landscape display. 337.92mm(H) x 422.4mm(V) atportrait display. Pixel pitch: 0.055mm(H) (sub-pixel pitch) x 0.165mm(V) at landscape display.0.165mm(H) x 0.055mm(V) (sub-pixel pitch) at portrait display
	• Communicating ports:Serial communication: USB (upstream x1, downstream x2)
2. Graphics card and software
	• Digital-to-Analog converters: speed and precision:Only Digital operation, Digital to Analog converters are not provided.• Software included: calibration, QC/QA (procedures with required frequencies and actionlimits):
	Totoku's calibration software called "Mediviser" optimizes the display's performance usingDICOM GSDF gamma and luminance. Calibration is recommended quarterly.• On-screen GUI: On-screen GUI is not provided.• Panel user controls: power switch
Technical Specification
1. Measuring EquipmentRefer to List
3. Luminance response	2. Declared and actual (measured with test pattern in the screen) array size:Declared array size (spec): 422.4mm(H) x 337.92mm(V)Actual array size (measured): 422.35mm(H) x 337.95mm(V)
• max and min achievable luminance:	[SPEC] Luminance Max (L.max)=1200cd/m2. Luminance Min (Lmin)= 0.5cd/m2
• max and min recommended (operational) luminance:	[SPEC] Luminance Max recommend: Lmax(r)=500cd/m2. Lmin(r)=0.8cd/m2
• intrinsic bit-depth of the panel: [SPEC] 8bit per each subpixel
	• true output bit-depth by performing visual test with gradient test pattern:[SPEC] 10.3bit gray scale (1276 steps) achieved by 11bit LUT (Look-up Table) in the Displayhardware.
	• intrinsic luminance response at 256 digital values:[SPEC] dJND per dP<3.000, dJNDs/dP max error<2.000.
	JNDs/dP RMS error<1.000
	Above spec is based on AAPM-TG18 Advanced Luminance Response. 4.3.5Refer to actual luminance response data
	• conformance to a grayscale function (i.e., DICOM GSDF) at 256 digital values and angulardependence of such conformance:
	[SPEC] Kσ within +- 10% deviation to DICOM GSDF based on AAPM-TG18Luminance Response 4.3.4
	Refer to actual luminance response data including angular dependence (Digital Driving Level vsDelta L, L.)
	• angular dependency of luminance:[SPEC] C1 R=175, K*=30%
4. Luminance uniformity	[SPEC] Less than 30% based on AAPM-TG18 4.4. Refer to actual luminanceuniformity data

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K131137
Page 4 of 4

[SPEC] Less than 2.0% based on A.APM-TG18, Refer to actual Geometrical Disturtion data 6. Display reflectance · Bi-directional reflection distribution function, or · specular and diffuse coefficients (ISO13406-2 by TUV) . [SPEC] Refer to Max allowable ambient luminance in Tables 4 and 5 on AAPM-TG18 4.2.4 Refer to actual Reflectance Data 7. Noise · Pixel fill factor (fefxos ISO 13406-2) ISPEC | 30% Min. Refer to Data of Pixel fill factor. · RMS (image variance) and noise power spectrum (weiner spectrum) ISPI C'10.1 Max at 0.6Hz. 3Hz. 30Hz Jitter. Refer to actual data 8. Veiling glare ISPI.C [Glare Ratio (GR) == 400 GR (I b=I m) (1 -1 m based on A \PM-1618 4,7,4 Reter to actual veiling glare ratio data 9. Chromaticity [SPEC] Delta (u', v') ≤ 0.01 measured at 809% Lmax based on AAPM-7018 4.8.4 Refer to Chromaticity actual data 10. Artifacts · pixel dropouts including spatial distribution (ISO13406-2 by TUV): [SPEC] Class (pixel) II. Refer to table 3 on 3.4.13 ISO13406-2 · phase/clock issues flicker · miscellaneous including ringing, ghosting, image sticking [SPEC] By visible check, no ringing, ghosting image sticking 11. Spatial resolution, spatial MTF DATA | Refer to actual MH data 12. Temporal response · Temporal MTF, or · rise and fall time constants for 5-95% and 40-60% transitions by { 'M(). |SPIC | Rise Time Tr. Full Time | f. Tr. 1 Fessons. Refer to actual data 13. Stability (possibly determined via temperature or time stress tests) by TUV · of luminance response, of temporal response, of described artifacts 18PEC] Ko within +2 10% deviation to DICOM (iSDF, based on AAPM-T(18 I uminance Response 4.3.4 via temperature stress 0 deg('. 25deg('. 40degC Refer to actual measured data

[fefxos = for example, following ... or similar]

Geometrical distortion

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Image /page/4/Picture/0 description: The image shows a circular logo with an emblem in the center. The emblem appears to be a stylized representation of an eagle or bird-like figure with three curved lines forming its body and wings. Encircling the emblem is text that reads 'DEPARTMENT OF HEALTH & HUMAN SERVICES USA' in a circular arrangement around the emblem.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drue Administration 10903 New Hampshire Avenue Document Control Center - WO66-G605 Silver Spring, MD 20993-0002

July 18, 2013

JVC KENWOOD Corporation % Mr. Tsukasa Tashiro General Manager 3-12, Moriya-cho, Kanagawa-ku, Yokohama-shi Kanagawa 221-0022 JAPAN

Rc: K131137

Trade/Device Name: 21.3 inch Monochrome Digital Mammography LCD Monitor MS5512 (ML21055, MD211G5)

Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 19, 2013 Received: April 23. 2013

Dear Mr. Tashiro:

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. Iisting 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 is 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 (2) 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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Page 2 - Mr. Tashiro

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resources/orYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

Smh.7)

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

for

Enclosure

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Indications for Use

K131137 510(k) Number (if known):

Device Name: 21.3 inch Monochrome Digital Mammography LCD Monitor MS55i2 (ML21055, MD211G5)

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

$\sinh p)$

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

210(k) K131137

Page 1 of 1

Regulation Number and Section

§ 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).