Home › Device types › MUH
System, X-Ray, Extraoral Source, Digital
FDA product code MUH · Class 2 · Dental
1,038
Registered devices
65
Adverse events
9
Recalls
207
510(k) clearances
Devices with this code
DEXIS IXS Size 2 Sensor - S — Dental Imaging Technologies CorporationSchick AE — SIRONA DENTAL, INC.SCHICK WIFI — SIRONA DENTAL, INC.Midmark OptiMax Digital Sensor System — MIDMARK CORPORATIONX-MIND prime — DE GÖTZEN SRLMidmark OptiMax Digital Sensor System — MIDMARK CORPORATIONPolaroid - Miri Trading LLC — VILLA SISTEMI MEDICALI SPAEDLENi Dental Sensor - Size 2 — EDLEN IMAGING, LLCImagen Gold Dental Sensors — TRIDENT SRLSnapshot — PaloDEx Group OyDEXIS IXS Size 2 Sensor Kit — Dental Imaging Technologies CorporationKaVo IXS Size 1 Sensor Kit — Dental Imaging Technologies CorporationSchick AE — SIRONA DENTAL, INC.FONA ELITE — SIRONA DENTAL, INC.KaVo IXS Size 2 Sensor Kit — Dental Imaging Technologies CorporationSCHICK WIFI — SIRONA DENTAL, INC.Digital Intraoral X-ray Imaging System — iRay GroupEzSensor — Rayence Co., Ltd.Pan system with ceph sensor, export — MIDMARK CORPORATIONOwandy Radiology — OWANDY RADIOLOGYSCAN CEPH — CARESTREAM HEALTH, INC.MISTERXRAY #2 — Dental Savings Club IncImagen Sensor BOOM — TRIDENT SRLSCHICK ELITE — SIRONA DENTAL, INC.
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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.