Atlas FDA

MUH

206 FDA 510(k) clearances · Product code

73 daysmedian time to decision
231 days90th percentile
206clearances measured

FDA profile

Official device name
System, X-Ray, Extraoral Source, Digital
Device class
Class II (moderate risk)
Regulation
21 CFR 872.1800
Medical specialty
Dental
Flags
Third-party review eligible
Adverse events (MAUDE)
2005: 3 · 2009: 12 · 2010: 9 · 2012: 5
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
SOTA Cloud Smart Sensor (1.5) (K251793)Sota Cloud Corp.2026-03-03
EzSensor HD, EzSensor UHD (K252570)Qpix Solutions, Inc.2025-11-10
Cocoon Solo (DX-7020s) (K250687)Dexcowin Global, Inc.2025-10-24
Digital X-Ray DentiMax Pro Imaging System (K251206)Dentimax, Inc.2025-09-24
VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan) (K240040)VATECH Co., Ltd.2024-10-25
X Sensor (Model: IOS-A15IF, HDI-15DGF) (K242778)Qpix Solutions, Inc.2024-10-11
DUO1 and DUO2 (K241649)Zinnovi, Inc.2024-07-05
RAYSCAN a-Expert (K232325)Ray Co., Ltd.2024-04-18
Digital image scanner of dental (K231660)Jiangsu Dynamic Medical Technology Co., Ltd.2023-12-20
DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor (K233053)Dental Imaging Technologies Corporation2023-11-21
TuxDeluxe (Size 1 6100B, Size 2 6101B) (K232552)Tuxedo Imaging, LLC2023-10-20
Digital Wireless Intraoral X-Ray Sensor (K230998)Iray Imaging Technology (Haining) Limited2023-10-20
WeSensor (K230916)Picopack, Inc.2023-10-10
EZSensor XHD (K232255)Qpix Solutions, Inc.2023-09-27
GenX-CR (K232158)Genoray Co., Ltd.2023-09-13
QuickRayPRO (K231202)Denterprise International, Inc.2023-06-22
Digital Intraoral X-Ray Sensor (K230811)Iray Imaging Technology (Haining) Limited2023-04-21
Eagle S/Saevo Slim/D700 Slim (K230732)Alliage S/A Industrias Medica Odontológico.2023-04-11
ScanX Swift 2.0, ScanX Swift View 2.0 (K230095)Durr Dental SE2023-02-06
Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20 (K221955)Realcloud Imaging Inc. Dba Realcloud Imaging2022-08-31
HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2) (K221008)Shanghai Handy Medical Equipment Co., Ltd.2022-06-22
PAPAYA & PAPAYA Plus (K220423)Genoray Co., Ltd.2022-05-19
OpenSensorX Series (K220556)Dentimax, Inc.2022-04-13
Dental sensors NanoPix1, NanoPix2 (K220422)Iray Technology Taicang , Ltd.2022-03-11
Dental Image Plate Scanner, Model DFC-4T-SMART (K214091)Hefei Dentafilm Medical Equipment Co., Ltd.2022-03-02
Digital Intraoral X-ray Sensor (K220277)Shenzhen Xpectvision Technology Co., Ltd.2022-02-17
JAZZ Solo sensor (K213637)Jazz Imaging, LLC Dba Jazz Imaging2021-12-10
Digital Intraoral X-ray Imaging System (K212279)Iray Technology Taicang , Ltd.2021-10-07
Imaging Plate Scanner, i-Scan (K212080)Guilin Woodpecker Medical Instrument Co., Ltd.2021-09-27
RXS 1000 (K202369)Rolence Enterprise, Inc.2021-09-15
StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2 (K212103)Fona S.R.L2021-08-30
CRUXVIEW (K211317)Cruxell Corp.2021-07-29
DC-Air and Athlos-1 and Athlos-Air (K211688)Athlos OY2021-07-22
PlutoX Digital Intraoral X-Ray Imaging System (K210312)Iray Technology Taicang , Ltd.2021-04-23
SensorX (K203116)Durr Dental SE2021-03-19
X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology) (K203374)De Götzen S.R.L.2021-02-05
Clio Prime and Clio Pedo (K202664)Sota Precision Optics, Inc. Dba Sota Imaging2020-11-06
ScanX Edge (K202633)Dürr Dental SE2020-10-07
I-View Gold and Imagen Gold Dental Sensors (K200625)Trident S.R.L2020-04-15
R-Sensor, R-Sensor (K200284)Remedi Co., Ltd.2020-02-28
X-MIND Trium (K191719)De Gotzen S.R.L.2020-02-20
Digital Intraoral Imaging Plate System (K192766)Fsusen Technology Co., Ltd.2019-12-05
ScanX Touch/ScanX Duo Touch (K191623)Air Techniques, Inc.2019-08-21
ODI HD Dental Sensor (K190234)Cnd Global Technologies, Inc.2019-03-01
Cruxcan (CRX-1000) (K183637)Cruxell Corp.2019-02-12
Panoura X-ERA PF/NF/MF (K182198)The Yoshida Dental Mfg. Co., Ltd.2019-01-31
DENTIOIII series (DENTIOIII, DENTIOIII-S) (K181297)Hdx Will Corp.2018-11-21
Aurora (K181636)Sodium Systems, LLC2018-07-20
Televere Digital Dental Imaging System (K181358)Televere Systems, Inc.2018-06-20
FS Ergo (K173646)Palodex Group OY2017-12-19
DEXIS Titanium, KaVo IXS HD (Size 1, Size 2) (K172918)Kavo Dental Technologies, LLC2017-12-18
Cocoon Portable Handheld X-Ray System (K173046)Dexcowin Co., Ltd.2017-10-26
Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology) (K162190)Villa Sistemi Medicali S.P.A.2017-07-06
ScanX Intraoral View (K170733)Duerr Dental AG2017-05-01
System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight (K170731)VATECH Co., Ltd.2017-04-04
Bel-Cypher Pro (K163175)Takara Belmont Corporation2017-03-20
JAZZ SOLO Sensor (K163224)Jazz Imaging, LLC2017-03-09
Apex Dental Sensors (K163282)Masterlink, LLC2017-02-28
I View and Imagen Sensor (K162619)Trident S.R.L2016-11-04
SuniIQ Digital Radiography System (K162585)Suni Medical Imaging, Inc.2016-11-04
FONA Pan/Ceph (K161131)Fona S.R.L2016-11-03
RIOScan (RPS500) (K160788)Ray Co., Ltd.2016-04-15
ReadeR, VieweR, QuickScan PSP (K160386)Trident S.R.L2016-03-10
TIO-H DIGITAL RADIOGRAPHY SENSOR (K153144)Denttio, Inc.2016-02-10
Myray- HYPERION X5 (K152162)Cefla S.C.2015-12-24
QuickRay HD Intraoral Sensor (K151926)Denterprise International, Inc.2015-12-14
Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S (K153060)Rayence Co., Ltd.2015-11-10
EDLENi Intra-Oral Sensor (K150823)Edlen Imaging, LLC2015-08-26
CS 8100SC, CS8100SC Access (K151087)Trophy2015-08-21
SOPIX (K142995)Sopro - Acteon Group2015-08-17
PSPIX 2 scanner, Imaging Plate Size 0 for PSPIX2 scanner, Imaging Plate Size 1 for PSPIX2 scanner, Imaging Plate Size 2 for PSPIX2 scanner, Imaging Plate Size 3 for PSPIX2 scanner (K151053)Sopro - Acteon Group2015-07-31
EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio i (K151707)Rayence Co., Ltd.2015-07-19
Digital Dental Intra Oral Sensor, EzSensor Smart (K150797)Rayence Co., Ltd.2015-05-01
RAYSCAN A-EXPERT (K142058)Ray Co., Ltd.2015-04-22
NICAL SMART MICRO CR system for intraoral dental images (K143703)Nical Spa2015-03-18
Digital Dental Intra Oral Sensor, EzSensor Soft, EzSensor Bio (K143753)Rayence Co., Ltd.2015-03-10
PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM (K141700)Genoray Co., Ltd.2014-10-31
SOPIX INSIDE, SOPIX2 INSIDE (K140013)Sopro - Acteon Group2014-09-05
ENCOMPASS (K141130)Panoramic Corp.2014-07-30
Z-RAY INTRA-ORAL DIGITAL RADIOGRAPHY SYSTEM (K133206)Zuma Dental, LLC2014-05-13
ADX4000W (K134055)Dexcowin Co., Ltd.2014-05-09
OPTEO, VIDEOGRAPH HD (K133271)Owandy2014-04-28
DX3000-L (K133007)Dexcowin Co., Ltd.2014-04-24
DIGORA OPTIME (K133231)Instrumentarium Dental, Palodex Group OY2014-03-20
PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM (K130419)Genoray Co., Ltd.2013-11-06
RAYSCAN A-EXPERT (K131693)Ray Co., Ltd.2013-11-01
FIRECR DENTALIMAGING SYSTEM (K131442)3Disc Americas2013-09-06
PORT VIEW, DIGITAL X-RAY SENSOR SYSTEM (K130088)Genoray Co., Ltd.2013-07-18
PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM, PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM (K130585)VATECH Co., Ltd.2013-07-15
RAYSCAN A-EXPERT (K122918)Ray Co., Ltd.2013-03-15
IMAGE WORKS PANOURA (K122806)Mic International2013-03-08
POINT 500 HD POINT500C HD (K121800)Pointnix Co., Ltd.2013-01-24
VANTAGE MODEL V5000, V5100, V5000C, V5100C (K122643)Midmark Corp.2013-01-07
EVA SELECT DIGITAL DENTAL IMAGING SYSTEM (K123419)Afp Imaging Corp.2012-12-27
PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM (K122155)VATECH Co., Ltd.2012-09-04
VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM (K120263)Genoray Co., Ltd.2012-07-10
CS 8100 CS 8100 ACCESS (K120975)Trophy2012-06-22
APIXIA DIGIREX DIGITAL DENTAL REDIOGRAPHY SYSTEM (K120106)Apixia, Inc.2012-05-07
PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM (K113672)VATECH Co., Ltd.2012-03-27
VIVI ERGON-X HF (K120318)Vivi S.R.L.2012-03-06
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