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FireCam HD Intraoral Camera
Digiray Corp. · Model FR61 · UDI-DI 08809466040610
10
510(k) clearances
47
Adverse events
1
Recalls
371
Facilities
Description
The advanced camera & optics technology of the FireCam HD IntraOral Camera enables you to produce high-quality digital images for diagnosing the patients in your facility. The reader can be used as a central reader, which distributes images throughout your facility, or as an exam-room based solution. The reader is DICOM 3.0 compatible with existing systems and uses a full range of low-cost. The design features a 360° touch-switch for capture operation.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-03-23 | Sunstar Americas, Inc. | Product may be contaminated with Burkholderia contaminans. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.