(24 days)
Not Found
No
The summary describes a medical display monitor and does not mention any AI or ML capabilities.
No.
The device is a monitor used for displaying medical images for diagnosis, not for providing therapy or treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device "is intended to be used in displaying and viewing medical images from PACS, endoscope and ultrasonograph for diagnosis by trained Medical practitioners." This explicit mention of "diagnosis" indicates its role in a diagnostic process.
No
The device description explicitly states it is a 24.1-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 clearly states that the device is for "displaying and viewing medical images from PACS, endoscope and ultrasonograph for diagnosis". This involves displaying images generated from medical procedures performed on a patient, not analyzing samples taken from a patient (which is the core of IVD).
- Device Description: The description details a monitor, which is a display device, not a device that performs tests on biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information about a patient's health status based on sample analysis
The device is a medical image display monitor, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
24.1 inch (61.1 cm) Color 2M pixel LCD Monitor CCL244 (CL24244) is intended to be used in displaying and viewing medical images from PACS, endoscope and ultrasonograph for diagnosis by trained Medical practitioners. It is not meant to be used in digital mammography.
Product codes (comma separated list FDA assigned to the subject device)
PGY
Device Description
CCL244 (CL24244) is a 24.1-inch (61.1 cm) Color LCD monitor whose display resolution is 1920 x 1200 (landscape), 1200 x 1920 (portrait) supporting multiple interfaces such as HDMI, BNC, S-video and HD-SDI in addition to DVI and D-Sub.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
PACS, endoscope and ultrasonograph
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)
The overall design of the CCL244 (CL24244) was 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 CCL244 (CL24244) 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 3, 2014
JVC KENWOOD CORPORATION
% Mr. Tsukasa Tashiro Senior Manager 3-12 Moriya-cho, Kanagawa-ku Yokohama-shi, Kanagawa, 221-0022 JAPAN
Re: K142540
Trade/Device Name: 24.1 inch (61.1 cm) Color LCD Monitor CCL244 (CL24244) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: September 5, 2014 Received: September 9, 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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Sm.f.f)
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
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) Not known K142540
Device Name CCL244 (CL24244)
Indications for Use (Describe)
24.1 inch (61.1 cm) Color 2M pixel LCD Monitor CCL244 (CL24244) is intended to be used in displaying and viewing medical images from PACS, endoscope and ultrasonograph 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)
区 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
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
TOTOKU
510(k) SUMMARY
| Submitted Information: | JVC KENWOOD CORPORATION
3-12, MORIYA-CHO, KANAGAWA-KU,
YOKOHAMA-SHI, KANAGAWA, 221-0022 JAPAN |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tsukasa Tashiro, Senior Manager
Email: tashiro.tsukasa@jvckenwood.com
Tel: +81.258.24.6611
Fax: +81.258.24.6617 |
| Date Prepared: | September 5, 2014 |
| Device Name: | 24.1 inch (61.1 cm) Color LCD Monitor CCL244 (CL24244) |
| Common Name: | CCL244, CL24244 |
| Classification Name: | Class II
(Part 892 Radiology Devices
Sec. 892.2050 Picture Archiving and Communication System) |
| Predicate Device: | 20.1 inch (51 cm) Color LCD Monitor CCL208 (CDL2013A)
(K092728). |
| Device Description: | CCL244 (CL24244) is a 24.1-inch (61.1 cm) Color LCD monitor
whose display resolution is 1920 x 1200 (landscape), 1200 x 1920
(portrait) supporting multiple interfaces such as HDMI, BNC,
S-video and HD-SDI in addition to DVI and D-Sub. |
| Intended Use: | 24.1-inch (61.1 cm) Color 2M pixel LCD Monitor, CCL244
(CL24244) is intended to be used in displaying and viewing
medical images from PACS, endoscope and ultrasonograph for
diagnosis by trained Medical practitioners. It is not meant to be
used in digital mammography. |
| Substantial Equivalence: | CCL244 (CL24244) shares the same technical characteristics and
application with our predicate device CCL208 (K092728). |
5
Technical Specification
-
- Luminance uniformity [SPEC] Less than 30% based on AAPM-TG18 4.4. Refer to actual Luminance uniformity data
-
- Pixel Defects / Fault [SPEC] Class II or more. ISO13406-2
-
- Artifacts
- phase/clock issues flicker
- · miscellaneous including ringing, ghosting, image sticking [SPEC] By visible check, no flicker, ringing, ghosting and image sticking
-
- Chromaticity Measurement of 5%, 50%, 95% Level [SPEC] Refer to actual data.
-
- Chromaticity
[SPEC] Delta (u', v') ≤ 0.01 measured at 80% Lmax based on AAPM-TG18 4.8.4 Refer to Chromaticity actual data
-
- Power On Luminance Drift [SPEC] Refer to actual data.
6
| CCL208 (CDL2013A) | CCL244 (CL24244) | |
|---|---|---|
| 510(k) Number | K092728 | Not Known |
| Display Area | Horizontal: 408.0mm, Vertical: 306.0mm | Horizontal: 518.0mm, Vertical: 324.0mm |
| Input Signal | Mini D-sub 15-pin connector (same connector) | |
| DVI-I 29-pin connector | Mini D-sub 15-pin connector (same connector) | |
| DVI-I 24-pin connector, HDMI connector, BNC connector, | ||
| S-Video connector, HD-SDI connector | ||
| Maximum Resolution | 1200 x 1600 at portrait display | |
| 1600 x 1200 at landscape display | 1920 x 1200 at landscape display | |
| 1200 x 1920 at portrait display | ||
| Scanning Frequency | Horizontal: 30 - 75kHz | |
| Vertical: 55 - 60Hz | Horizontal: 30 - 80kHz | |
| Vertical: 50 - 85Hz | ||
| Maximum Image Clock | 162MHz | 162MHz |
| Maximum Luminance | 300cd/m² | 300cd/m² |
| Luminance Calibration (Optional) | Software | |
| Photo Sensor (optional): X-Rite Chroma 5 | Software | |
| Photo Sensor (optional): X-Rite Chroma 5 | ||
| Serial Communication | DDC-ci based serial communication | RS-232C based serial communication (D-sub 9-pin) |
| Safety Standards | Medical Safety: MET (for US)/MET-C (for Canada), | |
| IEC60601-1, IEC60601-1-2, IEC60950-1, FCC-B, | ||
| VCCI-B, MDD/CE | Medical Safety: ANSI/AAMI ES60601-1, CAN/CSA C22.2 No. | |
| 60601-1, FCC (Class B), MDD/CE, VCCI-B (Class B), ICES-003 | ||
| (Class B), CCC | ||
| Weight & Dimension | Net: 10.7kg | |
| 453(w) x 462 - 523(H) x 220(D) mm | ||
| Packed: 15.5kg | ||
| 470(w) x 685(H) x 345(D) mm | Net: 7.1kg | |
| 560.2(w) x 363.8(H) x 100(D) mm | ||
| Packed: 9.2kg | ||
| 240(w) x 470(H) x 685(D) mm | ||
| Power Supply | 100-240V AC, 50/60Hz | 100-240V AC, 50/60Hz |
ubstantial Equivalence Compariso
7
CCL244 (CL24244) can be considered to have equivalent display performances to those of the predicate device CCL208 (K092728) due to the following reasons:
- a. CCL244 (CL24244) comes with a wider screen of 518mm x 324mm sized active display area with 19201200 sized maximum display compared to the predicate device CCL208 (K092728) with 408.0mm x 306.0mm active area and 16001200 sized maximum display.
- b. The DICOM calibrated luminance value of the predicate device CCL208 (K092728) is 120cd/m2, whereas that of CCL244 (CL24244) is set to a higher value of 200cd/m2. Both devices have 300cd/m2 for the highest luminance value. Moreover, by adopting LED backlighting system which lasts longer than the conventional CCFL's, CCL244 (CL24244) becomes capable of maintaining the brightness at the higher DICOM-calibrated luminance value for the same backlight life time as or even longer than the predicate device.
- c. The LED backlight was newly employed instead of CCFL backlight because it is mercury-free, consumes less power and deteriorates more 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. The predicate device CCL208 (K092728) supports DVI-D (digital interface) and D-Sub (analog interface), while CCL244 (CL24244) is compatible with multiple interfaces such as HDMI, BNC, S-video and HD-SDI in addition to DVI and D-Sub.
As for the maintenance, QA software is used for both devices. Adopting the LED current stabilization circuit for luminance stabilization, CCL244(CL24244) achieves equivalent or superior capability in stabilizing luminance to that of the predicate device CCL208 (K092728).
The overall design of the CCL244 (CL24244) was 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 CCL244 (CL24244) performs in accordance with its specifications. None of the tests revealed behaviors inconsistent with the expected performance.
Conclusion
The 2M pixel Color LCD Monitor, CCL244 (CL24244) is substantially equivalent to the predicate device with respect to technical characteristics and application. In terms of the intended use, the proposed device can be used for displaying medical images through endoscope and ultrasonograph besides PACS. The specifications of the primary component employed by the proposed device are the same to those of the predicate device and do not affect safety or effectiveness.