(19 days)
Not Found
No
The summary describes a medical monitor, which is a display device, and does not mention any AI or ML capabilities.
No.
The device is a display monitor for medical images and does not administer any form of treatment or therapy. Its intended use is for diagnosis, not therapy.
Yes
The product information explicitly states that the device "is intended to be used in displaying medical images for diagnosis."
No
The device description explicitly states it is a "2MP Color LCD Monitor CL-R211," 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 "displaying medical images for diagnosis." This describes a device that presents visual information to a user, not a device that performs tests on biological samples to diagnose a condition.
- Device Description: The device is a "2MP Color LCD Monitor." This is a display device, not a device designed to analyze biological materials.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Performing chemical, immunological, or molecular tests
- Providing results related to a patient's health status based on sample analysis
The device's function is to display images, which is a crucial part of the diagnostic process but is not the diagnostic test itself. The diagnosis is made by the trained medical practitioner interpreting the displayed images.
N/A
Intended Use / Indications for Use
CL-R211 (CL-R211xxxxx) is intended to be used in displaying medical images for diagnosis by trained medical practitioners or certified personnel.
It is not meant to be used in digital mammography.
Product codes (comma separated list FDA assigned to the subject device)
PGY
Device Description
CL-R211 : 1600 x 1200 (landscape), 1200 x 1600 (portrait)
DVI (digital interface) and DisplayPort (digital interface)
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 or certified personnel.
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)
Not Found
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.
CCL214 (CL21214/ K161895)
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).
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are simple and professional in appearance.
JVC Kenwood Corporation c/o Masafumi Yugami Manager 3-12, Moriya-cho, Kanagawa-ku Yokohama, Kanagawa 221-0022 JAPAN
October 3, 2018
Re: K182539
Trade/Device Name: 2MP Color LCD Monitor CL-R211 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: PGY Dated: September 12, 2018 Received: September 14, 2018
Dear Masafumi Yugami:
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 mav, 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 avare 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael D. O'Hara
for Robert A. 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
510(k) Number (if known)
Device Name 2MP Color LCD Monitor CL-R211
Indications for Use (Describe)
CL-R211 (CL-R211xxxxx) is intended to be used in displaying medical images for diagnosis by trained medical practitioners or certified personnel.
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) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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JVCKENWOOD
510(k) SUMMARY
| Submitted Information: | JVC KENWOOD Corporation
3-12, Moriya-cho, Kanagawa-ku,
Yokohama-shi, Kanagawa, 221-0022 Japan | |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person: | Masafumi Yugami, Manager
Email: yugami.masafumi@jvckenwood.com
Tel: +81-258-24-6611
Fax: +81-258-24-6617 | |
| Date Prepared: | September 12, 2018 | |
| Device Name: | 2MP Color LCD Monitor
CL-R211 | |
| Common Name: | CL-R211
(CL-R211xxxxx) | |
| Classification Name: | Class II
(Part 892 Radiology Devices
Sec. 892.2050 Picture Archiving and Communication System) | |
| Predicate Device: | 21.3 inch (54cm) Color LCD Monitor CCL214
(CL21214/ K161895) | |
| Device Description: |
CL-R211 : 1600 x 1200 (landscape), 1200 x 1600 (portrait)
DVI (digital interface) and DisplayPort (digital interface) | |
| Intended Use: | CL-R211 is intended to be used in displaying and viewing medical
images for diagnosis by trained medical practitioners or certified
personnel.
It is not meant to be used in digital mammography. | |
| Substantial Equivalence: | CL-R211 shares the same technical characteristics, application, and
intended use as our predicate device CCL214 (CL21214 / K161895) | |
JVC KENWOOD Corporation
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| Technical Specification |
|---|
| 1. Luminance Response |
| [SPEC] Less than $\pm$ 10% based on AAPM-TG18 4.3. |
| 2. Angular Dependencies |
| [SPEC] More than angle of 20° LR' $\delta$ , $\theta$ ≥ 175, k $\delta$ , $\theta$ ≤ 30% based on AAPM-TG18 4.4. |
| 3. Luminance Uniformity |
| [SPEC] Less than 30% based on AAPM-TG18 4.4.4 |
| 4. Pixel Defects / Fault |
| [SPEC] Class II or more. ISO13406-2 |
| 5. Artifacts |
- phase/clock issues flicker
- miscellaneous including ringing, ghosting, image sticking
[SPEC] By visible check, no flicker, ringing, ghosting and image sticking. |
| 6. Chromaticity Measurement of 5%, 50%, 95% Level |
| 7. Chromaticity
[SPEC] $\triangle$ (u' , v' ) ≤ 0.01 measured at 80% Lmax based on AAPM-TG18 4.8.4 |
| 8. Power On Luminance Drift
[SPEC] $\triangle$ Lmax≤ $\pm$ 10% within 60 seconds.
$\triangle$ Lmax : the deviation between the target maximum luminance and the measured luminance. |
| 9. Reflection
Based on AAPM-TG18 4.2. |
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Substantial Equivalence Comparison
| CCL214 (CL21214) | CL-R211(CL-R211xxxxx) | |
|---|---|---|
| 510(k) Number | K161895 | Not Known |
| Resolution or Matrix Size | 2MP(1200 x 1600) | 2MP(1200 x 1600) |
| Screen Technology | TFT Color LCD Panel (IPS) | TFT Color LCD Panel (IPS) |
| Backlighting | LED | LED |
| Maximum Luminance | 500 cd/m2 typ. | 500 cd/m2 typ. |
| DICOM | ||
| Calibrated Luminance | 250 cd/m² | 250 cd/m² |
| Viewing Angle | CR>10:1 | |
| Horizontal: Typ.178 Vertical: Typ.178 | CR>10:1 | |
| Horizontal: Typ.178 Vertical: Typ.178 | ||
| Display Area | Horizontal: 432.0mm, Vertical: 324.0mm | Horizontal: 432.0mm, Vertical: 324.0mm |
| Response Time (typical) | 10% – 90% | |
| Ton 8ms Typ. Toff 8ms Typ. | 10% – 90% | |
| Ton 8ms Typ. Toff 8ms Typ. | ||
| Aspect Ratio | 3:4 | 3:4 |
| Pixel Pitch | Horizontal: 0.270mm, Vertical: 0.270mm | Horizontal: 0.270mm, Vertical: 0.270mm |
| Contrast Ratio | 1200:1 | 1800:1 |
| Grayscale Tones | 10-bit (DisplayPort): 1,024from a palette of 65,473 tones | |
| 8-bit: 256 from a palette of65,473 tones | 10-bit (DisplayPort): 1,024from a palette of 65,473 tones | |
| 8-bit: 256 from a palette of65,473 tones | ||
| Non-Uniformity | ||
| Compensation | Uniformity correction System | Uniformity correction System |
| Input Video Signal | DVI-D 24-pin connector, DisplayPort connector | DVI-D 24-pin connector, DisplayPort connector |
| USB Ports / Standard | USB: upstream port (x 1), downstream port (x 2) | |
| Ver 2.0 | USB: upstream port (x 1), downstream port (x 2) | |
| Ver 2.0 | ||
| CCL214 (CL21214) | CL-R211(CL-R211xxxxx) | |
| Scanning Frequency | DVI | |
| Horizontal:74.1KHz, Vertical: 60Hz (Landscape) | ||
| Horizontal:98.1KHz, Vertical: 60Hz (Portrait) | ||
| DisplayPort | ||
| Horizontal:75.0KHz, Vertical: 60Hz (Landscape) | ||
| Horizontal:99.0KHz, Vertical: 60Hz (Portrait) | DVI | |
| Horizontal:74.1KHz, Vertical: 60Hz (Landscape) | ||
| Horizontal:98.1KHz, Vertical: 60Hz (Portrait) | ||
| DisplayPort | ||
| Horizontal:75.0KHz, Vertical: 60Hz (Landscape) | ||
| Horizontal:99.0KHz, Vertical: 60Hz (Portrait) | ||
| Maximum Image Clock | 162MHz | 162MHz |
| Rated | AC100-240V, 50/60Hz | |
| 1.4 - 0.7A | AC100-240V, 50/60Hz | |
| 2.2 - 1.1A | ||
| Luminance Calibration | ||
| (Optional) | Software | |
| Photo Sensor (optional): X-Rite i1Display | Software | |
| Photo Sensor (optional): X-Rite i1Display | ||
| Sensor | Built-in Front Sensor | |
| Built-in Ambient Light Sensor | ||
| None | Built-in Front Sensor | |
| Built-in Ambient Light Sensor | ||
| Built-in Human presence sensor | ||
| Safety Standards | ANSI/AAMI ES60601-1, CAN/CSA C22.2 No. 60601-1, | |
| FCC (Class B), ICES-003 (Class B), | ||
| MDD/CE, VCCI-B (Class B) | ANSI/AAMI ES60601-1, CAN/CSA C22.2 No. 60601-1, | |
| FCC (Class B), ICES-003 (Class B), | ||
| MDD/CE, VCCI-B (Class B) | ||
| Weight & Dimension | Net: 11.1kg | |
| 367.0(w) x 521.9 – 583.4(H) x 220(D) mm | ||
| Packed: Approx.14.0kg | ||
| 470(w) x 670(H) x 340.0(D) mm | Net: 8.9kg | |
| 361.5(w) x 517 – 612(H) x 196.5(D) mm | ||
| Packed: Approx.11.9kg | ||
| 585(w) x 580(H) x 285(D) mm |
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