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.
Device Story
RadiForce G51 is a 21.3-inch TFT monochrome LCD monitor designed for medical imaging, including digital mammography. It receives digital video input via DVI-D interface from a medical workstation. The device displays high-resolution (2048 x 2560) monochrome images to radiologists or clinicians in clinical environments. It features a 700 cd/m² brightness and 600:1 contrast ratio. The monitor supports optional luminance calibration via an external photo-sensor and software. The output provides visual diagnostic information to assist healthcare providers in clinical decision-making and image interpretation. It serves as a replacement for CRT-based display systems, offering a thinner form factor and specific luminance performance for diagnostic radiology.
Clinical Evidence
Bench testing only. No clinical data provided.
Technological Characteristics
21.3-inch TFT monochrome LCD panel; 0.165 mm pixel pitch; 2048 x 2560 native resolution; 700 cd/m² brightness; 600:1 contrast ratio; DVI-D 24-pin input; RS232/Mini DIN serial ports for remote control/sensor; AC power 100-240V; Standards: EN60601-1, UL2601-1, CSA C22.2 No. 601-1, FCC-A, VCCI-A.
Indications for Use
Indicated for use as a 5 Megapixel monochrome LCD monitor for medical imaging applications, including digital mammography systems, where the device meets the performance specifications required by the system manufacturer.
Regulatory Classification
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.
Special Controls
*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).
Predicate Devices
Barco NV Barcoview Digital Mammography Display Model MDG 521M (K033859)
Submission Summary (Full Text)
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K042755
510(k) Summary as required by 807.92
- 1. 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
- 2. Official Correspondent
Hiroaki Hashimoto (Mr.) Manager of Engineering Management Section
- 3. Date of Submission
October 4, 2004
- 4. Device Trade name RadiForce G51, 5 Megapixel Monochrome LCD Monitor
- 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: Barco NV Barcoview Device Name: Digital Mammography Display Model Name: MDG 521M 510(k) No.: K033859
- 8. 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.
- 9. 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.
- 10. 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.
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## 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<br>display |
| Picture Tube/Pixel Pitch | Faceplate transmission: 32%<br>Phosphor: P45 (standard) or P104 | 0.165 mm x 0.165 mm |
| Available Cabinet Colors | Black | Black |
| Scanning Frequency<br>(H, V) | H: 160-200kHz<br>V: 48-150Hz | H: 103.9 kHz<br>V: 50.06 Hz |
| Native Resolutions | 2048 x 2560 (portrait) | 2048 x 2560 (portrait)<br>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<br>9600 baud, RS232<br>SUB-D9 male/female<br>connector | D-Sub 9 pin (Remote Out),<br>Mini DIN 6 pin (Remote In),<br>Mini DIN 8 pin (Photo Sensor) |
| Active Display Size<br>(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)<br>Photo-sensor (Optional) | Software (Optional)<br>Photo-sensor (Optional) |
| Power | AC90-264V<br>50-60Hz | AC100V-120V/200V-240V,<br>50/60Hz, |
| Certifications &<br>Standards | cUL950, CE, IEC601-1,<br>UL2601-1, cUL2601, UL1950,<br>DIN 6868-57 | TUV/GM, CE, CB, EN60601-1,<br>UL2601-1, CSA C22.2 No. 601-1,<br>FCC-A, Canadian ICES-003-A,<br>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.
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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 _
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1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
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Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
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Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
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Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
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Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
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Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
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Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
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Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
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Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
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Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
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A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
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The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
