FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,589 results
7345–7368 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 08, 2007
HEXAPOD RT COUCH TOP
K071870 · JAI
Medical Intelligence Medizintechnik GmbH
Radiology · 2d
Cleared Jul 05, 2007
CORDLESS PORTABLE DENTAL X-RAY SYSTEM, MODEL ADX4000
K070811 · MUH
Dexco
Radiology · 101d
Cleared Jul 05, 2007
OLYMPUS XBF-UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE USED WITH ALOKA...
K070983 · PSV
Olympus Medical Systems Corporation
Radiology · 90d
Cleared Jul 05, 2007
DIGITAL STEREOLOC II
K071542 · IZH
Lorad, A Hologic Co.
Radiology · 30d
Cleared Jul 05, 2007
GE OEC ALTITUDE
K071717 · IZI
Shimadzu Corp.
Radiology · 13d
Cleared Jul 03, 2007
AOS UNIVERSAL CONECTING GUIDE TUBE
K062824 · JAQ
Alpha-Omega Services, Inc.
Radiology · 286d
Cleared Jul 03, 2007
SOUNMED SD-2000 PLUS PORTABLE ULTRASOUND SCANNER
K071156 · IYO
Sounmed, Inc.
Radiology · 69d
Cleared Jul 02, 2007
SIGMA M
K063837 · MUH
Instrumentarium Dental, Palodex Group OY
Radiology · 188d
Cleared Jul 02, 2007
MYLAB40
K070903 · ITX
Esaote Europe B.V.
Radiology · 91d
Cleared Jun 28, 2007
CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS
K071396 · KPT
Capintec, Inc.
Radiology · 38d
Cleared Jun 28, 2007
ECHELON SPECTROSCOPY PACKAGE
K071506 · LNI
Hitachi Medical Systems America, Inc.
Radiology · 27d
Cleared Jun 28, 2007
NEOCOIL 3.0T 8-CHANNEL SHOULDER ARRAY COIL
K071611 · MOS
Neocoil
Radiology · 15d
Cleared Jun 27, 2007
EZPACS, VERSION 3.0
K062878 · LLZ
Advanced Imaging Solutions, LLC
Radiology · 274d
Cleared Jun 27, 2007
REGIUS UNITEA
K071436 · LLZ
Konica Minolta Medical & Graphic, Inc.
Radiology · 35d
Cleared Jun 27, 2007
GE LUNAR BODY COMPOSITION SOFTWARE
K071570 · KGI
Ge Medical Systems Lunar
Radiology · 19d
Cleared Jun 26, 2007
INSPACE 4D SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY
K071513 · JAK
Siemens Medical Solutions
Radiology · 22d
Cleared Jun 22, 2007
IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION)
K071297 · LLZ
Agfa Healthcare Corp.
Radiology · 44d
Cleared Jun 22, 2007
X3C 2200 DIGITAL RADIOGRAPHIC SYSTEM
K071401 · KPR
Imaging Dynamics Company , Ltd.
Radiology · 32d
Cleared Jun 21, 2007
SYNERAD OMNI, MODELS AN6255 AND AN6265
K071430 · KPR
Analogic Corp.
Radiology · 29d
Cleared Jun 20, 2007
THD
K070815 · JAF
G.F. S.R.L.
Radiology · 86d
Cleared Jun 20, 2007
KHBS (KRISHNAMURTHY HEPATO-BILIARY SOFTWARE), MODEL VERSION 1.5
K071195 · IYX
Ani-Kal Ii, LLC
Radiology · 51d
Cleared Jun 20, 2007
IMAGE-ARENA APPLICATIONS AND RESEARCH-ARENA APPLICATIONS
K071232 · LLZ
Tomtec Imaging Systems GmbH
Radiology · 48d
Cleared Jun 20, 2007
XPERT 40 SPECIMEN RADIOGRAPHY SYSTEM
K071233 · MWP
Kub Technologies, Inc.
Radiology · 48d
Cleared Jun 20, 2007
DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODEL DVS-I-11: DVS...
K071399 · LHN
Sicel Technologies, Inc.
Radiology · 30d