FireCR Dental

Digiray Corp. · Model FR11 · UDI-DI 08809466040214

510(k) clearances

Adverse events

Recalls

Facilities

Description

The advanced CR technology of the FireCR Dental Reader 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, reusable bitewings and intraoral imaging plates. The design features a built-in erase function and a color touch-screen LCD panel without physical push buttons for seamless device operation.

Recalls

Date	Firm	Reason
2019-04-29	KaVo Dental Technologies LLC	The sensor's look up calibration files were incorrectly programmed during manufacturing, which can result in the reduction of image quality.
2015-08-05	Villa Radiology Systems LLC	It has been discovered that due to lack of information accompanying documents the product fails to comply with 21CfR 1020.33(c),1020.33(d),1020.33(g),and 1020.330).
2015-01-08	Carestream Health, Inc.	Units device head descended unexpectedly
2015-01-08	Carestream Health, Inc.	Units device head descended unexpectedly
2014-09-04	Midmark Corp dba Progeny Inc	Failure of the primary collimator may result in unintentional movement of the device. The unintentional movement will not result in the generation of an error message.
2013-09-20	Midmark Corp dba Progeny Inc	An error was identified in the Real Time Controller (RTC) firmware versions 3.0, 3.1, 3.2, and 3.3 used in Vantage Panoramic X-Ray systems. The error may cause the column of the Va
2009-03-06	Gendex Dental Systems	There is a compatibility issue when the VixWin Platinum versions 1.0/1.1/1.2 software is used in conjunction with Easy Dental, PracticeWorks, EagleSoft and SoftDent practice manage
2009-01-08	Imaging Sciences International, LLC	faulty calibration
2008-03-19	Imaging Sciences Intl Inc	Incorrect scatter information in the manual.

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Data 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.