Home › Device types › MUH
System, X-Ray, Extraoral Source, Digital
FDA product code MUH · Class 2 · Dental
1,029
Registered devices
65
Adverse events
9
Recalls
206
510(k) clearances
Devices with this code
X-MIND trium — DE GÖTZEN SRLXIOS XG WIFI — SIRONA DENTAL, INC.XIOS AE — SIRONA DENTAL, INC.RIOScan — Ray Co., LtdCS 8100SC — CARESTREAM DENTAL LLCDEXIS Titanium Warranty Replacement — Dental Imaging Technologies CorporationCS 8200 3D — CARESTREAM DENTAL LLCAcuity Direct X-Ray Photon Detection — CAO GROUP, INC.Schick AE — SIRONA DENTAL, INC.xgenus Vega HD — DE GÖTZEN SRLBELRAY II — TAKARA BELMONT CORP.PaX-i — VATECH CO., LTD.Digital Wireless Intraoral X-Ray Sensor — iRay GroupGenoray — GENORAY CO., LTD.Schick AE — SIRONA DENTAL, INC.Gendex GXS-700™ intraoral sensor — GENDEX CORP.CS 8100SC — CARESTREAM HEALTH, INC.CDR ELITE — SIRONA DENTAL, INC.Midmark Extraoral Imaging System (EOIS) — MIDMARK CORPORATIONKaVo GXS-700™ intraoral sensor — GENDEX CORP.DTE — Guilin Woodpecker Medical Instrument Co., Ltd.ScanX Duo — AIR TECHNIQUES, INC.SCHICK WIFI — SIRONA DENTAL, INC.DEXIS IXS Size 1 Sensor - R — Dental Imaging Technologies Corporation
Recent 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 1020.3 |
| 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 m |
| 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 |
| 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 Soft |
| 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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