(129 days)
No
The 510(k) summary describes a digital image display monitor and does not mention any AI or ML capabilities. The device description refers to a previous clearance from 2003, which predates the widespread use of AI/ML in medical devices.
No
The device is described as a "digital image display" used for "medical image applications," indicating it is for viewing and not for treatment.
No
The device is a monitor intended to display medical images. It does not perform any diagnostic function itself.
No
The device description explicitly states it is a "digital image display," which is a hardware component (a 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 the device is a "5 Megapixel Monochrome LCD Monitor" for displaying medical images, including those from digital mammography systems. This is a display device, not a test performed on biological samples.
- Device Description: The description confirms it's a "digital image display."
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory tests.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or treatment. This device's function is to display images generated by other medical devices.
N/A
Intended Use / Indications for Use
RadiForce G51 is intended to be used in various kinds of medical image applications including digital mammography system for which the device complies with the performance specified by the manufacturer of the system.
5 Megapixel Monochrome LCD Monitor, RadiForce G51 is intended to be used in various kinds of medical image applications including digital mammography system for which the device complies with the performance specified by the manufacturer of the system.
Product codes (comma separated list FDA assigned to the subject device)
90 LLZ
Device Description
RadiForce G51 device is a digital image display. Clearance letter (510(k) No. K032026, dated on AUG 27, 2003) had been issued. The device is qualified for various medical image applications including digital mammography system.
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
Not Found
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.
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) Summary as required by 807.92
-
- Company Identification
EIZO NANAO CORPORATION 153 Shimokashiwano cho, Matto shi, Ishikawa ken, 924-8566, Japan Tel: +81-76-274-2468 Fax: +81-76-274-2484
- Company Identification
-
- Official Correspondent
Hiroaki Hashimoto (Mr.) Manager of Engineering Management Section
- Official Correspondent
-
- Date of Submission
October 4, 2004
- Date of Submission
-
- Device Trade name RadiForce G51, 5 Megapixel Monochrome LCD Monitor
-
- Common/Usual Name:
Image display system, medical image workstation, image monitor/display, and others
-
- Classification Number:
Medical displays classified in Class II per 21 CFR 892.2050.
- Classification Number:
-
- Predicate Device
Manufacturer: Barco NV Barcoview Device Name: Digital Mammography Display Model Name: MDG 521M 510(k) No.: K033859
- Predicate Device
-
- Description of Device
RadiForce G51 device is a digital image display. Clearance letter (510(k) No. K032026, dated on AUG 27, 2003) had been issued. The device is qualified for various medical image applications including digital mammography system.
- Description of Device
-
- Intended Use
RadiForce G51 is intended to be used in various kinds of medical image applications including digital mammography system for which the device complies with the performance specified by the manufacturer of the system.
- Intended Use
-
- Substantial Equivalence to Predicate Device
RadiForce G51 is substantially equivalent to MDG 521M. G51 employs the maximum resolution values same as that of MDG 521M. Comparison table of the principal characteristics of 2 devices is shown in the Attachment 1 and specification data for the use of mammography system monitor is included in Attachment 8.
- Substantial Equivalence to Predicate Device
1
Appendix 1: Comparison Table with Predicate Device
| Items | MDG 521 (Predicate Device) | RadiForce G51 |
|---|---|---|
| 510(k) Number | K033859 | Not known |
| Panel Size and Type | 21" CRT display | 21.3" TFT monochrome LCD |
| display | ||
| Picture Tube/Pixel Pitch | Faceplate transmission: 32% | |
| Phosphor: P45 (standard) or P104 | 0.165 mm x 0.165 mm | |
| Available Cabinet Colors | Black | Black |
| Scanning Frequency | ||
| (H, V) | H: 160-200kHz | |
| V: 48-150Hz | H: 103.9 kHz | |
| V: 50.06 Hz | ||
| Native Resolutions | 2048 x 2560 (portrait) | 2048 x 2560 (portrait) |
| 2560 x 2048 (landscape) | ||
| Brightness | 450 cd/m² | 700 cd/m² |
| Contrast Ratio | 2000:1 | 600:1 |
| DOT Clock | 500MHz pixel clock | 152MHz |
| Input Signals | BNC | DVI Standard 1.0 |
| Input Terminals | BNC | DVI-D 24 pin x 1 |
| Serial Ports | 1 input, 1 output | |
| 9600 baud, RS232 | ||
| SUB-D9 male/female | ||
| connector | D-Sub 9 pin (Remote Out), | |
| Mini DIN 6 pin (Remote In), | ||
| Mini DIN 8 pin (Photo Sensor) | ||
| Active Display Size | ||
| (H x V) | 300 x 400 mm / 304 x 380 mm | 337.9 x 422.4 mm |
| Dimensions (W x H x D) | 558 x 400 x 561 mm | 388 x 572 x 83.5 mm |
| Luminance Calibration | Software (Optional) | |
| Photo-sensor (Optional) | Software (Optional) | |
| Photo-sensor (Optional) | ||
| Power | AC90-264V | |
| 50-60Hz | AC100V-120V/200V-240V, | |
| 50/60Hz, | ||
| Certifications & | ||
| Standards | cUL950, CE, IEC601-1, | |
| UL2601-1, cUL2601, UL1950, | ||
| DIN 6868-57 | TUV/GM, CE, CB, EN60601-1, | |
| UL2601-1, CSA C22.2 No. 601-1, | ||
| FCC-A, Canadian ICES-003-A, | ||
| VCCI-A, CCC |
*Since the software used in G51 is not changed, refer to the 510(k) Summary of K32026 for the information of calibration software.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Hiroaki Hashimoto Manager of Product Safety & EMC EIZO NANAO Corporation 153 Shimokashiwano, Matto Ishikawa 924-8566 JAPAN
Re: K042755
FEB 1 0 2005
Trade/Device Name: RadiForce G51 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system
Regulatory Class: II Product Code: 90 LLZ Dated: December 29, 2004 Received: January 3, 2005
Dear Mr. Hashimoto:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have reviewed your Section 510(ts) promantially equivalent (for the indications for use stated in above and have decemined the aboved icate devices marketed in interstate commerce prior to the enclosure) to regally maneled produced Device Amendments, or to devices that have been Way 26, 1770, the Chactified and of the Federal Food, Drug, and Cosmetic Act (Act) that reclassified in accordation was a proval application (PMA). You may, therefore, market the do not require approval of a prematics approvisions of the Act. The general controls provisions of the Act device, subject to the general one prove, 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 (Premarket If your device is classince (300 additional controls. Existing major regulations affecting your Apploval), It may oc subject to been aderal Regulations, Title 21, Parts 800 to 898. In addition, FDA uevice can oc round in the cenents concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Frease oc advisor mar PDT 5 tookies of the vice complies with other requirements of the Act or any FDA has made a decemination and your as the Federal agencies. You must comply with all the Federal statues and regulations administer of of east and listing (21 CFR Part 807); labeling Act s requirements, mediating practice requirements as set forth in the quality systems (QS) (21 CFR Part 801); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icuer will anow you to oogin maneeing your antial equivalence of your device to a legally premarket nothleation. The I DA mainly of bassamal sepproceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your device of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, prease note the regulation on your responsibilities under the Act from the 807.97). I ou may onam only general missistance at its toll-free number (800) DVISIon of 311an Mandracturers, Internet address http://www.fda.gov/cdrb/dsma/dsmamain.html
Sincerely yours,
Nancy C. brogdon
Nancy C. Brogdon
Nancy C. Brogdon 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 (if known):
Device Name: RadiForce G51
Indications For Use:
5 Megapixel Monochrome LCD Monitor, RadiForce G51 is intended to be used in various 5 Megapixel Monochrome HOD including digital mammography system for which the Kinds of medical mage appeacations specified by the manufacturer of the system.
Prescription Use
(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)
David A. Laymon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _