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HDI-P
Rayence Co., Ltd. · Model HDI-U10DF · UDI-DI 08800018600436
MUH
Prescription
10
510(k) clearances
65
Adverse events
9
Recalls
90
Facilities
Description
Digital Dental Intra Oral Sensor is a device which acquires digital intra-oral images. Direct digital systems acquire images with a sensor that is connected to a computer to produce an image almost instantaneously following exposure. The primary advantage of direct sensor systems is the speed with which images are acquired. For patient comfort, the ergonomic design is based on human intraoral anatomy.
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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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.