FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,620 results
7369–7392 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 16, 2007
SATURN 9000
K063710 · MQB
New Medical Co., Ltd.
Radiology · 214d
Cleared Jul 16, 2007
VARISOURCE IX HDR AFTERLOADER
K071467 · JAQ
Varian Medical Systems, Inc.
Radiology · 48d
Cleared Jul 12, 2007
MODIFICATION TO SUPERDIMENSION/BRONCHUS PREMIUM 2
K071473 · EOQ
Superdimension, Ltd.
Radiology · 44d
Cleared Jul 11, 2007
BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM, VERSION 6
K070611 · IYE
Nomos Corp.
Radiology · 128d
Cleared Jul 11, 2007
SOYEE PORTABLE X-RAY UNIT, MODEL SY-HF-110
K070634 · IZL
Soyee Product, Inc.
Radiology · 126d
Cleared Jul 11, 2007
EASYGUIDE
K071599 · LLZ
Keystone Dental, Inc.
Radiology · 30d
Cleared Jul 09, 2007
CONFIRMA BREAST MRI INTERVENTIONAL COMPONENTS
K071534 · MOS
Confirma, Inc.
Radiology · 34d
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