(42 days)
CCL214/K161895
No
The 510(k) summary describes a medical display monitor and does not mention any AI or ML capabilities.
No.
The device is used for displaying and viewing medical images for diagnosis, which is a diagnostic function, not a therapeutic one. It does not actively treat a condition.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is "intended to be used in displaying and viewing medical images for diagnosis."
No
The device description explicitly mentions hardware components (DVI and DisplayPort interfaces) and resolutions, indicating it is a physical display device, not solely software. The predicate device is also a physical monitor.
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 for diagnosis". This describes a device that presents information to a user, not a device that performs a test on a biological sample to provide diagnostic information.
- Device Description: The description details the technical specifications of a monitor (resolution, interfaces). This aligns with a display device, not an IVD.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Reagents or assays
- Measurement of biomarkers or analytes
- Providing a diagnostic result based on a test performed on a sample
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
CL-S200 (CL-S200xxxxx) and CL-S300 (CL-S300xxxxx) are 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.
Product codes
PGY
Device Description
Resolution
CL-S200 : 1600 x 1200 (landscape), 1200 x 1600 (portrait)
CL-S300 : 2048 x 1536 (landscape), 1536 x 2048 (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)
CCL214 (CL21214/K161895)
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).
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December 14, 2017
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
JVC KENWOOD Corporation % Masafumi Yugami Manager 3-12, Moriya-cho, Kanagawa-ku Yokohama. Kanagawa 221-0022 JAPAN
Re: K173434
Trade/Device Name: 2MP Color LCD Monitor CL-S200, 3MP Color LCD Monitor CL-S300 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: November 17, 2017 Received: November 20, 2017
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 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Masafumi Yugami
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.
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 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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Indications for Use
510(k) Number (if known) K173434
Device Name 2MP Color LCD Monitor CL-S200 3MP Color LCD Monitor CL-S300
Indications for Use (Describe)
CL-S200 (CL-S200xxxxx) and CL-S300 (CL-S300xxxxx) are 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.
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) |
|---|
| ----------------------------------------------- |
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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: | November 1, 2017 | |
| Device Name: | 2MP Color LCD Monitor CL-S200
3MP Color LCD Monitor CL-S300 | |
| Common Name: | CL-S200 (CL-S200xxxxx)
CL-S300 (CL-S300xxxxx) | |
| 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-S200 : 1600 x 1200 (landscape), 1200 x 1600 (portrait)
CL-S300 : 2048 x 1536 (landscape), 1536 x 2048 (portrait)
DVI (digital interface) and DisplayPort (digital interface) | |
| Intended Use: | CL-S200 and CL-S300 are 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-S200 and CL-S300 share 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. Angular Dependencies
| [SPEC] More than angle of 20° LR'δ ,θ ≥ 175, kδ ,θ ≤ 30% based on AAPM-TG18 4.4. |
|---|
| 2. Luminance Response |
| [SPEC] Less than 10% based on AAPM-TG18 4.3. |
| 3. Luminance Uniformity |
| [SPEC] Less than 30% based on AAPM-TG18 4.4.4 |
| 4. Reflection |
| Based on AAPM-TG18 4.2. |
| 5. Chromaticity |
| [SPEC] Δ (u' , v' ) ≤ 0.01 measured at 80% Lmax based on AAPM-TG18 4.8.4 |
| 6. Chromaticity Measurement of 5%, 50%, 95% Level |
| 7. Artifacts |
| · phase/clock issues flicker |
| · miscellaneous including ringing, ghosting, image sticking |
| [SPEC] By visible check, no flicker, ringing, ghosting and image sticking. |
| 8. Pixel Defects / Fault |
| [SPEC] Class II or more. ISO13406-2 |
| 9. Power On Luminance Drift |
| [SPEC] ΔLmax≤±10% within 60 seconds. |
| ΔLmax : the deviation between the target maximum luminance and the measured luminance. |
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Substantial Equivalence Comparison
| CCL214(CL21214) | CL-S200xXXXX | |
|---|---|---|
| 510(k) Number | K161895 | — |
| 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. | 1000 cd/m2 typ. |
| DICOM | ||
| Calibrated Luminance | 250 cd/m² | 500 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): 1,024 | |
| from a palette of 65,473 tones | ||
| 8-bit: 256 from a palette of | ||
| 65,473 tones | 10-bit (DisplayPort): 1,024 | |
| from a palette of 65,473 tones | ||
| 8-bit: 256 from a palette of | ||
| 65,473 tones | ||
| Non-Uniformity | ||
| Compensation | Uniformity correction | |
| System | Uniformity correction | |
| System | ||
| Input Video Signal | DVI-D x1 | |
| DisplayPort x1 | DVI-D x1 | |
| DisplayPort x1 | ||
| 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 | ||
| Scanning Frequency | DVI | |
| 74.1KHz, Vertical: 60Hz | ||
| (Landscape) | ||
| 98.1KHz, Vertical: 60Hz (Portrait) | ||
| DisplayPort | ||
| 75.0KHz, Vertical: 60Hz (Landscape) | ||
| 99.0KHz, Vertical: 60Hz (Portrait) | DVI | |
| 74.1KHz, Vertical: 60Hz | ||
| (Landscape) | ||
| 98.1KHz, Vertical: 60Hz (Portrait) | ||
| DisplayPort | ||
| 75.0KHz, Vertical: 60Hz (Landscape) | ||
| 99.0KHz, Vertical: 60Hz (Portrait) | ||
| Dot Clock | 162 MHz | 162 MHz |
| Rated | AC100-240V, 50/60Hz | |
| 1.4 – 0.7A | AC100-240V, 50/60Hz | |
| 2.2-1.1A | ||
| Luminance Calibration | Software: FCAL | |
| Calibration Sensor (Optional): i1 Display (X-Rite) | Software: FCAL | |
| Calibration Sensor (Optional): i1 Display (X-Rite) | ||
| Sensor | Built-in Front Sensor | Built-in Front Sensor |
| Sensor | Built-in Ambient Light Sensor | Built-in Ambient Light Sensor |
| None | Built-in Human presence sensor | |
| 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) | ||
| Dimensions | ||
| w/o Stand | ||
| (W x H x D) | Net: 11.1kg | |
| 474(w) x 468.4 - 529.9(H) x 220(D) mm (Landscape) | ||
| 367(w) x 524.9 - 586.4(H) x 220(D) mm (Portrait) | ||
| Packed: 14.0kg | ||
| 470(w) x 670(H) x 34(D) mm | Net: 9.2kg | |
| 493(w) x 451.3-546.3(H) x 196.5(D) mm (Landscape) | ||
| 361.5(w) x 517-612(H) x 196.5(D) mm | ||
| (Portrait) | ||
| Packed: 12.0kg | ||
| 585(w) x 580(H) x 285(D) mm | ||
| CCL214(CL21214) | CL-S300xxxXXX | |
| 510(k) Number | K161895 | — |
| Resolution or Matrix Size | 2MP(1200 x 1600) | 3MP(1536 x 2048) |
| Screen Technology | TFT Color | |
| LCD Panel (IPS) | TFT Color | |
| LCD Panel (IPS) | ||
| Backlighting | LED | LED |
| Maximum Luminance | 500 cd/m2 typ. | 1000 cd/m2 typ. |
| DICOM | ||
| Calibrated Luminance | 250 cd/m² | 500 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: 433.15mm, | |
| Vertical: 324.86mm | ||
| Response Time (typical) | 10% - 90% | |
| Ton 8ms Typ. | ||
| Toff 8ms Typ. | 10% - 90% | |
| Ton 15ms Typ. | ||
| Toff 15ms Typ. | ||
| Aspect Ratio | 3:4 | 3:4 |
| Pixel Pitch | Horizontal: 0.270mm | |
| Vertical: 0.270mm | Horizontal: 0.2115mm | |
| Vertical: 0.2115mm | ||
| Contrast Ratio | 1200:1 | 1500:1 |
| Grayscale | ||
| Tones | 10-bit (DisplayPort): 1,024 | |
| from a palette of 65,473 tones | ||
| 8-bit: 256 from a palette of | ||
| 65,473 tones | 10-bit (DisplayPort): 1,024 | |
| from a palette of 65,473 tones | ||
| 8-bit: 256 from a palette of | ||
| 65,473 tones | ||
| Non-Uniformity | ||
| Compensation | Uniformity correction | |
| System | Uniformity correction | |
| System | ||
| Input Video Signal | DVI-D x1 | |
| DisplayPort x1 | DVI-D x1 | |
| DisplayPort x1 | ||
| 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 | ||
| Scanning Frequency | DVI | |
| 74.1KHz, Vertical: 60Hz | ||
| (Landscape) | ||
| 98.1KHz, Vertical: 60Hz (Portrait) | ||
| DisplayPort | ||
| 75.0KHz, Vertical: 60Hz (Landscape) | ||
| 99.0KHz, Vertical: 60Hz (Portrait) | DVI (Dual Link) | |
| 93.1KHz, Vertical: 60Hz | ||
| (Landscape) | ||
| 123.9KHz, Vertical: 60Hz | ||
| (Portrait) | ||
| DisplayPort | ||
| 94.77KHz, Vertical: 59.98Hz | ||
| (Landscape) | ||
| 126.33KHz, Vertical: 59.96Hz | ||
| (Portrait) | ||
| Dot Clock | 162 MHz | 216 MHz |
| Rated | AC100-240V, 50/60Hz | |
| 1.4 - 0.7A | AC100-240V, 50/60Hz | |
| 2.2-1.1A | ||
| Luminance Calibration | Software: FCAL | |
| Calibration Sensor (Optional): i1 Display (X-Rite) | Software: FCAL | |
| Calibration Sensor (Optional): i1 Display (X-Rite) | ||
| 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), 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) | ||
| Dimensions | ||
| w/o Stand | ||
| (W x H x D) | Net: 11.1kg | |
| 474(w) x 468.4 - 529.9(H) x 220(D) mm (Landscape) | ||
| 367(w) x 524.9 - 586.4(H) x 220(D) mm (Portrait) | ||
| Packed: 14.0kg | ||
| 470(w) x 670(H) x 34(D) mm | Net: 10.3kg | |
| 493(w) x 451.3-546.3(H) x 196.5(D) mm (Landscape) | ||
| 361.5(w) x 517-612(H) x 196.5(D) mm (Portrait) | ||
| Packed: 13.0kg | ||
| 585(w) x 580(H) x 285(D) mm |
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