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
8137–8160 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Feb 16, 2005
VARIAN NASOPHARYNX APPLICATOR
K042360 · JAQ
Varian Medical Systems, Inc.
Radiology · 169d
Cleared Feb 15, 2005
USCOM 1A
K043139 · IYN
Uscom, Ltd.
Radiology · 95d
Cleared Feb 15, 2005
ACHIEVA FAMILY
K043147 · LNH
Philips Medical Systems North America...
Radiology · 92d
Cleared Feb 15, 2005
NEURO II-S
K050132 · LNH
Innovative Magnetic Resonance Imaging...
Radiology · 25d
Cleared Feb 15, 2005
MODIFICATION TO ACUSON CV70 CARDIOVASCULAR SYSTEM
K050240 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 13d
Cleared Feb 11, 2005
LUCION
K050033 · LLZ
Mevisys Co., Ltd.
Radiology · 35d
Cleared Feb 10, 2005
MONOCHROME LCD MONITOR, RADIFORCE G51
K042755 · LLZ
Eizo Nanao Corporation
Radiology · 129d
Cleared Feb 09, 2005
SMD 21500 OR DSB-2103-D-5MP-5M PIXEL GRAYSCALE FLAT PANEL DISPLAY
K043122 · LLZ
Siemens AG
Radiology · 89d
Cleared Feb 09, 2005
SONALIS, MODEL 2000
K043189 · IYO
3g Ultrasound, Inc.
Radiology · 84d
Cleared Feb 09, 2005
ORTHOPANTOMOGRAPH OP200, OP200D, AND ORTHOCEPH OC200, OC200D
K043612 · EHD
Instrumentarium Corp. Imaging Division
Radiology · 41d
Cleared Feb 09, 2005
MULTIDIAGNOST ELEVA
K050151 · KPR
Philips Medical Systems North...
Radiology · 16d
Cleared Feb 08, 2005
CHISON 600M WITH C60 CONVEX PROBE, L700 LINEAR PROBE
K050167 · IYO
Chison Medical Imaging Co., Ltd.
Radiology · 13d