System, X-Ray, Extraoral Source, Digital
Regulation 872.1800
3510(k)s in 12 months (207 all time)
0recalls in 12 months (9 all time)
9recalls that name a 510(k)
Top companies in MUH
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 29, 2019 | KaVo Dental Technologies LLC DEXIS Titanium Intraoral Sensor
Product Usage:
The DEXIS Titanium Intraoral Sensor is a USB-driven sensor which is intended to acquire dental intraoral radiographic images. The DEXIS / KaVo sensor sh Terminated |
MUH | K172918 |
| Nov 6, 2015 | Villa Radiology Systems LLC Villa Sistemi Rotograph EVO 3D X-ray Terminated |
MUH | K111152 |
| Apr 3, 2015 | Carestream Health, Inc. CS 8100 3D, CATALOG # (s): 5311162, 5311188.
Intended to produce complete or segmented tomographic digital panoramic X-ray images and three-dimensional digital X-ray images of the dentomaxillo-facial Terminated |
MUH | K133406 |
| Apr 3, 2015 | Carestream Health, Inc. CS 8100, CATALOG # (s): 5303045, 5311129, 5303060, 5303110
Intended to produce complete or segmented tomographic digital panoramic X-ray images to be used at the direction of healthcare professionals Terminated |
MUH | K120975 |
| Sep 4, 2014 | Midmark Corp dba Progeny Inc Vantage Panoramic X-Ray System used to perform dental and orthodontic radiological imaging
The Vantage Panoramic X-Ray System is a class II extra oral X-Ray system used to provide dental radiographic Terminated |
MUH | K122643 |
| Jan 9, 2014 | Midmark Corp dba Progeny Inc The Vantage Digital Panoramic System delivers high-value features standard on every system: - Five pre-programmed exam settings, including bitewing, minimize exam set-up time and allow routine diagnos Terminated |
MUH | K122643 |
| Jul 17, 2009 | Gendex Dental Systems Gendex VixWin Platinum Imaging Software, Versions 1.0, 1.1 and 1.2; Gendex Dental Systems, 901 West Oakton Street, Des Plaines, IL 60018.
Intended for use of the software is to control capture, displ Terminated |
MUH | K060178 |
| May 22, 2009 | Imaging Sciences International, LLC Gendex CB-500, 3D Dental Imaging Systems, Model Number G1-15-1-0. This product is manufactured by Imaging Sciences International for Gendex Corporation. Terminated |
MUH | K061284 |
| Sep 1, 2008 | Imaging Sciences Intl Inc i-CAT 17-19 Cone Beam 3D Dental Imaging System. This product is also sold under a private label as KaVo 3D eXam Terminated |
MUH | K061284 |
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