(22 days)
Not Found
No
The summary describes a medical monitor for displaying images, with no mention of AI/ML capabilities, image processing, or performance metrics typically associated with AI/ML algorithms.
No
The device is an LCD monitor used for displaying medical images for diagnosis; it is not a device that provides therapy.
No
The device is a medical image display monitor, which means it displays medical images for diagnosis, but it does not perform the diagnosis itself.
No
The device description explicitly states it is a 6M 30.0-inch Color LCD monitor, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to display and view medical images for diagnosis. This involves interpreting images generated by other medical devices (like X-ray machines, CT scanners, etc.), not analyzing samples taken from the human body (like blood, urine, tissue).
- Device Description: The device is a monitor, a display technology. IVD devices are typically instruments, reagents, or systems used to examine specimens from the human body.
- Lack of IVD-related information: There is no mention of analyzing biological samples, reagents, or any processes related to in vitro testing.
Therefore, the CCL650i2 (CL30650, MD302C6) is a medical image display device, not an IVD.
N/A
Intended Use / Indications for Use
6M pixel 30.0 inch Color LCD Monitor, CCL650i2 (CL30650, MD302C6) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used for digital mammography.
Product codes
LLZ
Device Description
CCL650i2 (CL30650, MD302C6) is a 6M 30.0-inch Color LCD monitor whose display resolution is 3280 x 2048 supporting DVI (digital visual interface) and DisplayPort.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained medical practitioners
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
JVC KENWOOD Corporation performed a range of system and performance tests to ensure that the CCL650i2 (CL30650, MD302C6) performs in accordance with its specifications. None of the tests revealed behaviors inconsistent with the expected performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
FEB 1 9 2014
TOTOKU
K140214
Page 1 of 5
510(k) SUMMARY
| Submitted Information: | JVC KENWOOD CORPORATION
3-12, MORIYA-CHO, KANAGAWA-KU,
YOKOHAMA-SHI, KANAGAWA, 221-0022 JAPAN | | | | |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|
| Contact Person: | Tsukasa Tashiro, General Manager
Email: tashiro.tsukasa@jvckenwood.com
Tel: +81.258.24.6611
Fax: +81.258.24.6617 | | | | |
| Date Prepared: | January 20, 2014 | | | | |
| Device Name: | 6M 30.0 inch Color LCD Monitor CCL650i2 (CL30650, MD302C6) | | | | |
| Common Name: | CCL650i2, CL30650, MD302C6 | | | | |
| Classification Name: | Class II
(Part 892 Radiology Devices
Sec. 892.2050 Picture Archiving and Communication System) | | | | |
| Predicate Device: | 21.3 inch (54 cm) Color LCD Monitor CCL358i2 (CL21358)
(K133185) | | | | |
| Device Description: | CCL650i2 (CL30650, MD302C6) is a 6M 30.0-inch Color LCD
monitor whose display resolution is 3280 x 2048 supporting DVI
(digital visual interface) and DisplayPort. | | | | |
| Intended Use: | 6M pixel 30.0 inch Color LCD Monitor, CCL650i2 (CL30650,
MD302C6) is intended to be used in displaying and viewing
medical images for diagnosis by trained medical practitioners. It is
not meant to be used for digital mammography. | | | | |
| Substantial Equivalence: | CCL650i2 (CL30650, MD302C6) realizes 2 (two) 3M screens of the
predicate device CCL358i2 (CL21358) (K133185) in one device.
The characteristics of CCL650i2 (CL30650, MD302C6) achieves
more than that of 2 (two) 3M monitors, CL358i2 (CL21258)
(K133185). The both devices do not share common components. | | | | |
JVC KENWOOD Corporation
Professional & Healthcare Division 3-12, Moriya-cho, Kanagawa-ku, Yokohama-shi, Kanagawa, 221-0022 Japan
1
Technical Specification
- Luminance uniformity: [SPEC] Less than 30% based on AAPM-TG18 4.4. Refer to actual Luminance uniformity data 2. Pixel Defects / Fault [SPEC] Class II or more. ISO13406-2 3. Artifacts • pixel defects/faults (ISO13406-2): · artifacts: miscellaneous including ringing, ghosting, image sticking 4. Chromaticity Measurement of 5%, 50%, 95% Level
[SPEC] Refer to actual data. 5. Chromaticity [SPEC] Delta (u', v') ≤ 0.01 measured at 80% Lmax based on AAPM-TG18 4.8.4 Refer to actual chromaticity data.
2
| CCL35812 (CL21358) | CCL650i2 (CL30650, MD302C6) | |
|---|---|---|
| 510(k) Number | K133185 | Unknown |
| Display Area | Horizontal: 433.152mm, Vertical: 324.864mm | Horizontal: 645.504mm, Vertical: 403.0464mm |
| Input Signal | DVI-D Digital Video Signal, DisplayPort | DVI-D Digital Video Signal, DisplayPort |
| Maximum Display | 1536 x 2048 dots | 3280 x 2048 dots |
| Pixel Pitch | 0.2115 x 0.2115mm | 0.197 x 0.197mm |
| DVI | DVI/DisplayPort | |
| Scanning Frequency | 46.6KHz, Vertical: 30Hz (Landscape) | |
| 61.9KHz, Vertical: 30Hz (Portrait) | ||
| 93.1KHz, Vertical: 60Hz (Landscape) | ||
| 123.9KHz, Vertical: 60Hz (Portrait) | ||
| DisplayPort | ||
| 47.4KHz, Vertical: 30Hz (Landscape) | ||
| 63.2KHz, Vertical: 30Hz (Portrait) | ||
| 94.8KHz, Vertical: 60Hz (Landscape) | ||
| 126.3KHz, Vertical: 60Hz (Portrait) | 126.5KHz, Vertical: 60Hz (3M) *1 | |
| 123.8KHz, Vertical: 60Hz (3M PLUS) *2 | ||
| 63.2KHz, Vertical: 30Hz (6M) *3 | ||
| 61.9KHz, Vertical: 30Hz (6M PLUS) *4 |
*1 3M=1536 x 2048
*2 3M PLUS=1640 x 2048
*3 6M=3072 x 2048
*4 6M PLUS=3280 x 2048 |
| Maximum Luminance | 410 cd/m² DICOM calibrated
800 cd/m² typ.as LCD component | 410 cd/m² DICOM calibrated
800 cd/m² typ.as LCD component |
| Luminance Calibration
(Optional) | Software: Medivisor Nx
Calibration Sensor: Chroma5 (X-Rite) | Software: Medivisor Nx
Calibration Sensor: Chroma5 (X-Rite) |
| Contrast Ratio | 1400:1 | 1000:1 |
| Serial Communication | USB: upstream port (x 1), downstream port (x 2) | USB: upstream port (x 1), downstream port (x 2) |
| Safety Standards | ANSI/AAMI ES60601-1, CAN/CSA C22.2 No.60601-1, FCC
(Class B), MDD/CE, VCCI-B (Class B) | ANSI/AAMI ES60601-1, CAN/CSA C22.2 No.60601-1, FCC
(Class B), MDD/CE, VCCI-B (Class B) |
| Weight & Dimension | Net: 12kg
474(w) x 468.4 - 529.9(H) x 220(D) mm (Landscape)
367(w) x 521.9 - 583.4(H) x 220(D) mm (Portrait)
Packed: 15.0kg
470(w) x 670(H) x 340(D) mm | Net: 15.5kg
695.6(w) x 512.1 - 573.6(H) x 243.5(D) mm
Packed: 20.3kg
791(w) x 690(H) x 344(D) mm |
| Power Supply | 100-240V AC 50/60Hz | 100-240V AC 50/60Hz |
ubstantial Equivalence Compariso
3
CCL650i2 (CL30650, MD302C6) can be considered to have equivalent display performances to those of the predicate device CCL358) (K133185) due to the following reasons:
- a. The maximum display size (3280 x 2048) is twice or more larger than that of the predicate device (1536 x 2048) and the active area size (645.504mm (H) x 403.0464mm (V)) is larger than that of the predicate device (433.152mm (H) x 324.864mm (V)). The proposed 6M device realizes two 3M screens in one device.
- b. The DICOM calibrated luminance values of the both devices are the same (410 cd/m² and the typical maximum luminance values are also same (800 cd/m²) between the both devices. The high luminance to be maintained constantly was realized by the employment of LED backlight deteriorating more slowly than conventional CCFL backlights.
- c. The LED backlight is employed with both CCL650i2 (CL30650, MD302C6) and the predicate device CCL358i2 (CL21358) (K133185) because it is mercury-free, consumes less power and deteriorates slowly. We have not recognized any adverse effects of the LED backlight on the quality of displayed images. Refer to "Technical Data" where several image quality characteristics of the proposed device are compared with those of the predicate device.
- d. The both devices display images in accordance with DICOM GSDF by default utilizing the factory calibrated display mode stored in lookup tables inside of them.
- e. Both devices support Digital Visual Interface (DVI) and DisplayPort.
- Pixel pitch of CCL650i2 (CL30650, MD302C6) 0.197mm x 0.197mm is smaller than that f. of the oredicate device CCL358i2 (CL21358) (K133185) 0.2115mm x 0.2115mm. The proposed device can display image more finely than the predicate device.
- g. CCL650i2 (CL30650, MD302C6) can display in 6 modes: 1) Full DVI (6M) 3280 x 2048 (30Hz) 2) Input 1: DVI (3M) 1640 x 2048 (60Hz), Input 2: DVI (3M) 1640 x 2048 (60Hz) 3) Input 1: DVI (3M) 1640 x 2048 (60Hz), Input 2: DP (3M) 1640 x 2048 (60Hz) 4) Input 1: DP (3M) 1640 x 2048 (60Hz), Input 2: DVI (3M) 1640 x 2048 (60Hz) 5) Input 1: DP (3M) 1640 x 2048 (60Hz), Input 2: DP (3M) 1640 x 2048 (60Hz) 6) Full DP (6M) 3280 x 2048 (30Hz) This unique characteristics is only for the proposed device.
As for the maintenance, the same QC software is used for both devices. Both devices have Front Sensor to stabilize the luminance.
As for built-in sensors, both devices have 2 (two) kinds of common sensors, Front Sensor and Ambient Light Sensor. Front Sensor is related to the maintenance or calibration and Ambient Light Sensor is used to measure the ambient light by Ix. Front sensor enables automatic grayscale calibration by measuring the luminance at the screen surface. Without Front sensor, the grayscale calibration process requires human intervention and the use of and external sensor. The accuracy data of the calibration with external sensors and that with Front Sensor is included in section 9 "Verification" in "Application".
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K140214
Page 5 of 5
The overall design of the CCL650i2 (CL30650, MD302C6) has been validated in accordance with internationally recognized Safety and EMC standards by third-party certifiers. Besides, JVC KENWOOD Corporation performed a range of system and performance tests to ensure that the CCL650i2 (CL30650, MD302C6) performs in accordance with its specifications. None of the tests revealed behaviors inconsistent with the expected performance.
Conclusion
The 6M pixel Color LCD Monitor, CCL650i2 (CL30650, MD302C6) is substantially equivalent to 2 (two) of the predicate 3M device with respect to technical characteristics, application and intended use. The specifications of the primary component employed by the proposed device are not the same to those of the predicate device, but the proposed device has been accepted by the same Safety Standards of the predicate device and the differences have been independently validated. Any differences between the devices do not affect safety or effectiveness. Therefore, the proposed device CCL650i2 (CL30650, MD302C6) were determined to be substantially equivalent to the predicate device CCL358i2 (CL21358) (K133185).
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993.0002
February 19. 2014
JVC KENWOOD Corporation % Mr. Tsukasa Tashiro General Manager 3-12. Moriya-Cho. Kanagawa-Ku Yokohama-Shi. Kanagawa 221-0022 JAPAN
Re: K140214
Trade/Device Name: 6M 30.0 inch Color I.CD Monitor CCL650i2 (C1.30650, MD302C6) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ. Dated: January 21, 2014 Received: January 28, 2014
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 `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 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.
6
Page 2—Mr. Tashiro
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/ResourcesforYou/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/Salctv/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Sm.h.7)
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
7
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| Form Approved: OMB No. 0910-0120 |
|---|
| Expiration Date: January 31, 2017 |
| See PRA Statement on last page. |
| 510(k) Number (if known) | K140214 |
|---|---|
| Not known |
| Device Name |
|---|
| CCI.650i2 (CI.30650, MD302C6) |
Indications for Use (Describe)
6M pixel 30.0 inch Color LCD Monitor CCL650i2 (CL30650. MD302C6) is intended to be used in displaying and viewing medical images for diagnosis by trained Medical practitioners. It is not meant to be used in digital mammography.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
[] Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
| FOR FDA USE ONLY | |
|---|---|
| Health (CDRH) (Signature) |
Concurrence of Center for Devices and Radiological Health (C
Sm.h.7)
FORM FDA 3881 (1/14)
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