(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 display monitor for viewing medical images, not a device that provides therapy or treatment.
Yes
Explanation: The device is intended for "displaying and viewing digital images for diagnosis," which is a diagnostic function even if it doesn't process the images itself.
No
The device description explicitly states it is a "48cm (19") Color LCD display," which is a hardware component.
Based on the provided information, the RadiForce RS110 is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis. The RadiForce RS110 is a display device used to view digital images generated by medical imaging modalities like X-ray and MRI. It does not interact with or analyze biological specimens.
- The intended use clearly states it's for "displaying and viewing digital images for diagnosis of X-ray or MRI, etc." This describes a device that presents visual information, not one that performs tests on biological samples.
Therefore, the RadiForce RS110 falls under the category of a medical image display device, not an IVD.
N/A
Intended Use / Indications for Use
RadiForce RS110 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. RadiForce RS110 does not support the display of mammography images for diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
RadiForce RS110 is a 48cm (19") Color LCD display for medical image viewing. RS110 displays high-definition medical imaging.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray or MRI
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)
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.
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
510(k) Summarv as required by 807.92
OCT 0 6 2008
1. Company Identification
EIZO NANAO CORPORATION 153 Shimokashiwano-cho, Hakusan-shi, Ishikawa-ken, 924-8566, Japan Tel: +81-76-274-2468 Fax: +81-76-274-2484
2. Official Correspondent
Hiroaki Hashimoto (Mr.) Manager of Product Safety
3. Date of Submission
September 11, 2008
4. Device Trade name
Color LCD Monitor, RadiForce RS110
5. Common/Usual Name
Image display system, medical image workstation, image monitor/display, and others
6. Classification Number
Medical displays classified in Class II per 21 CFR 892.2050.
7. Predicate Device
Manufacturer : EIZO NANAO CORPORATION Device Name .. Color LCD Monitor : RadiForce R12 Model Name 510(k) No. : K040982
8. Description of Device
RadiForce RS110 is a 48cm (19") Color LCD display for medical image viewing. RS110 displays high-definition medical imaging.
9. Intended Use
RadiForce RS110 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. RadiForce RS110 does not support the display of mammography images for diagnosis.
10. Technological Characteristics
RadiForce R12 is substantially equivalent to RS110 employs the maximum resolution values same as that of R12. RS110 improved the brightness, contrast and viewing angle of the LCD module, and modified the calibration software. The brightness improved in 290 cd/m2 from 270cd/m2. The contrast improved by it.
Comparison table of the principal characteristics of 2 devices is shown in the Attachment 1.
1
| Items | R12 | RS110 |
|---|---|---|
| 510(k) Number | K040982 | Not Known |
| Panel Size and Type | 48cm (19") | Same as R12 |
| Pixel Pitch | 0.294 mm x 0.294 mm | Same as R12 |
| Available Cabinet Colors | Black | Same as R12 |
| Display Colors | 16.77 million from a palette of 1.06 | |
| billion colors | Same as R12 | |
| Viewing Angles | H: 170°, V: 170° | H: 176°, V: 176° |
| Scanning Frequency | ||
| (H, V) | Digital: 30-65kHz 59-61Hz | |
| (VGA Text:65-71Hz) | ||
| Analog: 30-82kHz 49-86Hz | ||
| (1280 x 1024 : 49-76Hz) | ||
| Frame synchronous mode: | ||
| 57.5-62Hz | Same as R12 | |
| Native Resolutions | 1280 x 1024 | Same as R12 |
| Brightness | 270 cd/m² | 290 cd/m² |
| Contrast Ratio | 450 : 1 (typical) | 800 : 1 (typical) |
| DOT Clock | Digital 108 MHz, Analog: 135 MHz | Same as R12 |
| Response Time | 20 ms (typical) | 25 ms (typical) |
| Input Signals | Digital: DVI Standard 1.0, | |
| Analog: RGB Analog | Same as R12 | |
| Input Terminals | DVI-D 29 pin x 2 | D-Sub mini 15pin, DVI-I 29pin |
| (swichable) | ||
| USB Ports / Standard | 1 upstream, 2 downstream / Rev. | |
| 2.0 | Same as R12 | |
| Active Display Size | ||
| (H x V) | 376.3 mm x 301.0 mm | Same as R12 |
| Viewable Image Size | 481 mm (diagonal) | Same as R12 |
| Luminance Calibration | Software (Optional) | |
| Photo-sensor (Optional) | Same as R12 | |
| Power | AC100-120V/200-240V, 50/60Hz | Same as R12 |
| Power Management | DVI-DMPM | |
| VESA DMPM | Same as R12 | |
| Power Consumption | 60 watts (typical) | 55 watts |
| Power Save Mode | Less than 8 watts | Less than 1.3 watts |
| Dimensions | ||
| (W x H x D) | With Stand: | |
| 414 x 409.5 - 509.5 x 203 mm | ||
| Without Stand: | ||
| 414 x 340 x 64 mm | Same as R12 | |
| NET Weight | With Stand: 8.1 kg | |
| Without Stand: 5.8 kg | With Stand: 7.6 kg | |
| Without Stand: 5.3 kg | ||
| Certifications & | ||
| Standards | TUV/GM, CE Medical Device | |
| Directive, CB (EN60601-1), | ||
| cTUVus (UL2601-1, CSA C22.2 | ||
| No. 601-1), FCC-B, Canadian | ||
| ICES-003-B, VCCI-B, EIZO ECO | ||
| Products 2002 | CE (Medical Device Directive), | |
| TUV/GM (EN60601-1), cTUVus | ||
| (UL 60601-1, CSA C22.2 No. | ||
| 601-1), VCCI-B, FCC-B, | ||
| Canadian ICES-003-B, c-Tick, | ||
| EPA ENAERGY STAR®, EIZO | ||
| Products 2009, RoHS |
Appendix 1: Comparison Table with Predicate Device
*The software used in RS110 is modified, refer to the "12. Information of Software used in
RS110".
:
:
and the contraction of the comments of
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 0 6 2008
Mr. Hiroaki Hashimoto Manager EIZO NANAO Corporation Product Safety 153 Shimokashiwano-cho Hakusan, Ishikawa-ken, 924-8566 JAPAN
Re: K082663
Trade/Device Name: Color LCD Monitor, RadiForce RS110 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 11, 2008 Received: September 12, 2008
Dear Mr. Hashimoto:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
forpe M. Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number: KOS2663
Color LCD Monitor, RadiForce RS110 Device Name :
Indications for Use:
RadiForce RS110 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. RadiForce RS110 does not support the display of mammography images for diagnosis.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number, K082663