FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology × Cleared only ×
15,433 results
7969–7992 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 18, 2005
UNISCAN, PULMOSCAN, PULMOSCAN RADIOGRAPHIC SYSTEMS
K033577 · KPR
Medlink Imaging
Radiology · 491d
Cleared Mar 18, 2005
STARSHIELD V3 RF TRNT
K050237 · LNH
Odin Medical Technologies , Ltd.
Radiology · 44d
Cleared Mar 18, 2005
550 TXT TREATMENT TABLE
K050422 · JAI
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared Mar 17, 2005
ARTHORALIX 8500, MODELS 110-0199G1, 110-0199G2, 110-0199G3, 110-0199G4
K050255 · EHD
Gendex Dental Systems
Radiology · 42d
Cleared Mar 17, 2005
IMAGENPRO
K050366 · KPS
Cardiovascular Imaging Technologies, LLC
Radiology · 31d
Cleared Mar 17, 2005
GE DISCOVERY VCT SYSTEM
K050559 · KPS
GE Medical Systems
Radiology · 14d
Cleared Mar 11, 2005
VISION
K042956 · IYE
Varian Medical Systems, Inc.
Radiology · 135d
Cleared Mar 11, 2005
INNOVA 2100
K050489 · OWB
Ge Medical Systems, LLC
Radiology · 14d
Cleared Mar 10, 2005
TSX-201A AQUILION LB CT SCANNER
K050458 · JAK
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared Mar 01, 2005
SOMATOM EMOTION 16
K050297 · JAK
Siemens Medical Solution, Inc. USA
Radiology · 22d
Cleared Feb 28, 2005
SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL...
K043425 · ITX
Sheathing Technologies, Inc.
Radiology · 77d
Cleared Feb 28, 2005
MAGNETOM TRIO A TIM SYSTEM
K050200 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 31d
Cleared Feb 28, 2005
IPACS PRISM-5.0
K050298 · LLZ
Realtimeimage, Inc.
Radiology · 21d
Cleared Feb 28, 2005
AIRIS ELITE RAPID BODY COIL
K050307 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 20d
Cleared Feb 28, 2005
7350 ULTRASOUND IMAGING SYSTEM, MODEL 7350
K050326 · IYN
Esaote, S.P.A.
Radiology · 19d
Cleared Feb 25, 2005
MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM
K050347 · GEH
Endocare, Inc.
Radiology · 14d
Cleared Feb 24, 2005
KODAK ORTHODONTIC IMAGING AND OMS IMAGING 8.0
K043104 · EHD
Practiceworks, Inc.
Radiology · 107d
Cleared Feb 24, 2005
SECTRA IDS5 WORKSTATION
K050196 · LLZ
Sectra-Imtec AB
Radiology · 28d
Cleared Feb 24, 2005
HRK-123 KNEE ARRAY COIL
K050299 · MOS
Mri Devices Corporation
Radiology · 17d
Cleared Feb 23, 2005
XARIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-660A
K050380 · IYN
Toshiba America Medical Systems, In.C
Radiology · 8d
Cleared Feb 18, 2005
MAGNETOM SYMPHONY A TIM SYSTEM
K050199 · LNH
Siemens Medical Solution
Radiology · 21d
Cleared Feb 18, 2005
AGFA HEARTLAB CARDIOVASCULAR
K050228 · LLZ
Heartlab, Inc.
Radiology · 17d
Cleared Feb 17, 2005
SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-200
K043379 · OXO
Shimadzu Corp.
Radiology · 71d
Cleared Feb 17, 2005
FUKUDA DENSHI MODEL UF-850XTD
K050363 · IYN
Fukuda Denshi USA, Inc.
Radiology · 3d