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
7633–7656 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 05, 2006
CORONIS COLOR 2MP AND MDCC 2121
K061928 · LLZ
Barcoview
Radiology · 60d
Cleared Sep 01, 2006
AGFA MODEL CR30-X
K062223 · MQB
Agfa Corporation
Radiology · 30d
Cleared Sep 01, 2006
GE VANTAGE PET NEURO SOFTWARE
K062393 · KPS
Ge Healthcare
Radiology · 16d
Cleared Aug 24, 2006
MODIFICATION TO PHILIPS AVALON FETAL MONITORS FM20 AND FM30
K062137 · HGM
Philips Medizin Systeme Boeblingen GmbH
Radiology · 29d
Cleared Aug 23, 2006
APOLLO GAMMA CAMERA SYSTEM
K062298 · KPS
Adac Laboratories
Radiology · 15d
Cleared Aug 21, 2006
NOVAPACS, NOVAVIEW, NOVACARDIO, NOVAQC AND NOVAER
K061920 · LLZ
Novarad Corp.
Radiology · 46d
Cleared Aug 21, 2006
LEKSELL GAMMA KNIFE PERFEXION, MODEL 715000
K061941 · IWB
Elekta Instrument AB
Radiology · 42d
Cleared Aug 21, 2006
VITREAACCESS, VERSION 1.0
K062328 · LLZ
Vital Images, Inc.
Radiology · 11d
Cleared Aug 18, 2006
SONOMARK
K061560 · ITX
Medical Products Manufacturing, Inc.
Radiology · 74d
Cleared Aug 18, 2006
VERT-X
K061873 · OXO
Direx Systems Corp.
Radiology · 46d
Cleared Aug 18, 2006
CORONIS 2MP AND MDCG 2121 - CB
K061926 · LLZ
Barcoview
Radiology · 42d
Cleared Aug 18, 2006
HHF1 ECHELON MULTI-PURPOSE COIL
K061950 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 39d
Cleared Aug 18, 2006
SECURVIEW DX DIAGNOSTIC WORKSTATION, MODELS SV-0001, SV-0002 AND SV-0003
K062107 · LLZ
Hologic, Inc.
Radiology · 25d
Cleared Aug 18, 2006
HD11 DIAGNOSTIC ULTRASOUND SYSTEM
K062247 · IYN
Philips Ultrasound, Inc.
Radiology · 15d
Cleared Aug 17, 2006
MICROSELECTRON V3, MODEL 106.990
K061354 · JAQ
Nucletron Corporation
Radiology · 94d
Cleared Aug 17, 2006
XAMINER
K061595 · KPR
Imaging Dynamics Company , Ltd.
Radiology · 70d
Cleared Aug 17, 2006
SIEMENS ACUSON X500 ULTRASOUND SYSTEM
K061980 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 35d
Cleared Aug 17, 2006
CXDI-40EC
K062221 · MQB
Canon, Inc.
Radiology · 15d
Cleared Aug 15, 2006
FAXITRON DIGITAL RADIOGRAPHY SYSTEM, MODEL DX-50
K061361 · MWP
Faxitron X-Ray Corp.
Radiology · 91d
Cleared Aug 15, 2006
9900 PLUS MOBILE FLUOROSCOPY SYSTEM WITH 3D AND NAVIGATION OPTIONS
K061953 · OWB
Ge Oec Medical Systems
Radiology · 36d
Cleared Aug 15, 2006
DRY LASER IMAGER, DRYPRO MODEL 832
K061999 · LMC
Konica Minolta Medical & Graphic, Inc.
Radiology · 32d
Cleared Aug 11, 2006
NEURO II-SE, MODELS OR-MB-DR AND OR-DR
K061916 · LNH
Imris, Inc.
Radiology · 36d
Cleared Aug 10, 2006
VOLCANO S51 FAMILY OF IMAGING SYSTEMS
K061215 · IYO
Volcano Corporation
Radiology · 100d
Cleared Aug 10, 2006
NEUROQUANT
K061855 · LLZ
Cortechs Labs, Inc.
Radiology · 41d