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
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 19, 2017 | K173646 | FS Ergo Palodex Group OY, FI | MUH |
| Dec 18, 2017 | K172918 | DEXIS Titanium, KaVo IXS HD (Size 1, Size 2) Kavo Dental Technologies, LLC | MUH |
| Oct 26, 2017 | K173046 | Cocoon Portable Handheld X-Ray System Dexcowin Co., Ltd., KR | MUH |
| Jul 6, 2017 | K162190 | Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology) Villa Sistemi Medicali S.P.A., IT | MUH |
| May 1, 2017 | K170733 | ScanX Intraoral View Duerr Dental AG, DE | MUH |
| Apr 4, 2017 | K170731 | System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight VATECH Co., Ltd., KR | MUH |
| Mar 20, 2017 | K163175 | Bel-Cypher Pro Takara Belmont Corporation, JP | MUH |
| Mar 9, 2017 | K163224 | JAZZ SOLO Sensor Jazz Imaging, LLC | MUH |
| Feb 28, 2017 | K163282 | Apex Dental Sensors Masterlink, LLC | MUH |
| Nov 4, 2016 | K162619 | I View and Imagen Sensor Trident S.R.L, IT | MUH |
| Nov 4, 2016 | K162585 | SuniIQ Digital Radiography System Suni Medical Imaging, Inc. | MUH |
| Nov 3, 2016 | K161131 | FONA Pan/Ceph Fona S.R.L, IT | MUH |
| Apr 15, 2016 | K160788 | RIOScan (RPS500) Ray Co., Ltd., KR | MUH |
| Mar 10, 2016 | K160386 | ReadeR, VieweR, QuickScan PSP Trident S.R.L, IT | MUH |
| Feb 10, 2016 | K153144 | TIO-H DIGITAL RADIOGRAPHY SENSOR Denttio, Inc. | MUH |
| Dec 24, 2015 | K152162 | Myray- HYPERION X5 Cefla S.C., IT | MUH |
| Dec 14, 2015 | K151926 | QuickRay HD Intraoral Sensor Denterprise International, Inc. | MUH |
| Nov 10, 2015 | K153060 | Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S Rayence Co., Ltd., KR | MUH |
| Aug 26, 2015 | K150823 | EDLENi Intra-Oral Sensor Edlen Imaging, LLC | MUH |
| Aug 21, 2015 | K151087 | CS 8100SC, CS8100SC Access Trophy, FR | MUH |
| Aug 17, 2015 | K142995 | SOPIX Sopro - Acteon Group, FR | MUH |
| Jul 31, 2015 | K151053 | PSPIX 2 scanner, Imaging Plate Size 0 for PSPIX2 scanner, Imaging Plate Size 1 for PSPIX2 scanner, Imaging Plate Size 2 Sopro - Acteon Group, FR | MUH |
| Jul 19, 2015 | K151707 | EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio i Rayence Co., Ltd., KR | MUH |
| May 1, 2015 | K150797 | Digital Dental Intra Oral Sensor, EzSensor Smart Rayence Co., Ltd., KR | MUH |
| Apr 22, 2015 | K142058 | RAYSCAN A-EXPERT Ray Co., Ltd. | MUH |
| Mar 18, 2015 | K143703 | NICAL SMART MICRO CR system for intraoral dental images Nical Spa, IT | MUH |
| Mar 10, 2015 | K143753 | Digital Dental Intra Oral Sensor, EzSensor Soft, EzSensor Bio Rayence Co., Ltd., KR | MUH |
| Oct 31, 2014 | K141700 | PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM Genoray Co., Ltd. | MUH |
| Sep 5, 2014 | K140013 | SOPIX INSIDE, SOPIX2 INSIDE Sopro - Acteon Group | MUH |
| Jul 30, 2014 | K141130 | ENCOMPASS Panoramic Corp. | MUH |
| May 13, 2014 | K133206 | Z-RAY INTRA-ORAL DIGITAL RADIOGRAPHY SYSTEM Zuma Dental, LLC | MUH |
| May 9, 2014 | K134055 | ADX4000W Dexcowin Co., Ltd. | MUH |
| Apr 28, 2014 | K133271 | OPTEO, VIDEOGRAPH HD Owandy | MUH |
| Apr 24, 2014 | K133007 | DX3000-L Dexcowin Co., Ltd. | MUH |
| Mar 20, 2014 | K133231 | DIGORA OPTIME Instrumentarium Dental, Palodex Group OY, FI | MUH |
| Nov 6, 2013 | K130419 | PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM Genoray Co., Ltd. | MUH |
| Nov 1, 2013 | K131693 | RAYSCAN A-EXPERT Ray Co., Ltd. | MUH |
| Sep 6, 2013 | K131442 | FIRECR DENTALIMAGING SYSTEM 3Disc Americas | MUH |
| Jul 18, 2013 | K130088 | PORT VIEW, DIGITAL X-RAY SENSOR SYSTEM Genoray Co., Ltd. | MUH |
| Jul 15, 2013 | K130585 | PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM, PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM VATECH Co., Ltd. | MUH |
| Mar 15, 2013 | K122918 | RAYSCAN A-EXPERT Ray Co., Ltd. | MUH |
| Mar 8, 2013 | K122806 | IMAGE WORKS PANOURA Mic International, JP | MUH |
| Jan 24, 2013 | K121800 | POINT 500 HD POINT500C HD Pointnix Co., Ltd. | MUH |
| Jan 7, 2013 | K122643 | VANTAGE MODEL V5000, V5100, V5000C, V5100C Midmark Corp. | MUH |
| Dec 27, 2012 | K123419 | EVA SELECT DIGITAL DENTAL IMAGING SYSTEM Afp Imaging Corp. | MUH |
| Sep 4, 2012 | K122155 | PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM VATECH Co., Ltd. | MUH |
| Jul 10, 2012 | K120263 | VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM Genoray Co., Ltd. | MUH |
| Jun 22, 2012 | K120975 | CS 8100 CS 8100 ACCESS Trophy, FR | MUH |
| May 7, 2012 | K120106 | APIXIA DIGIREX DIGITAL DENTAL REDIOGRAPHY SYSTEM Apixia, Inc. | MUH |
| Mar 27, 2012 | K113672 | PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM VATECH Co., Ltd. | MUH |
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