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
6385–6408 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 20, 2010
SHIMADZU COLLIMATOR R-300
K101039 · IZW
Shimadzu Corp.
Radiology · 159d
Cleared Sep 16, 2010
MYRAY HYPERION
K101661 · MUH
Cefla Dental Group
Radiology · 94d
Cleared Sep 15, 2010
IMIX PANORAD AND SOMARAD
K101435 · KPR
Imix Adr Finland OY
Radiology · 117d
Cleared Sep 15, 2010
ECO SUPERGEL
K101429 · IYO
Ceracarta Spa
Radiology · 117d
Cleared Sep 15, 2010
EMBRACE
K101373 · IZH
Izi Medical Products, Inc.
Radiology · 121d
Cleared Sep 07, 2010
INFINIX-I INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V
K101868 · OWB
Toshiba America Medical Systems, In.C
Radiology · 67d
Cleared Sep 03, 2010
ECLIPSE TREATMENT PLANNING SYSTEM
K102011 · MUJ
Varian Medical Systems, Inc.
Radiology · 49d
Cleared Sep 03, 2010
BIOGRAPH MCT FAMILY
K101550 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 91d
Cleared Aug 31, 2010
MR RADIATION ONCOLOGY OPTIONS
K102155 · LNH
Ge Medical Systems, LLC
Radiology · 32d
Cleared Aug 31, 2010
GE LOGIQ P5 MODEL H44662LD
K101878 · IYN
Ge Healthcare
Radiology · 56d
Cleared Aug 31, 2010
MYLABONE ULTRASOUND SYSTEM
K101605 · IYN
Esaote Europe B.V.
Radiology · 84d
Cleared Aug 31, 2010
CS-SERIES-FP
K100102 · OWB
Omega Medical Imaging, Inc.
Radiology · 230d
Cleared Aug 31, 2010
1.5 TESLA 16- CHANNEL RECEIVE-ONLY PHASED- ARRAY HEAD COIL FOR SIEMANS
K093689 · MOS
Mr Medical Solutions, LLC
Radiology · 274d
Cleared Aug 27, 2010
14-CHANNEL EXTREMITY COIL FOR MAGNETOM ESSENZA
K100141 · MOS
Siemens Medical Solutions USA, Inc.
Radiology · 220d
Cleared Aug 26, 2010
TENZING SYSTEM
K102130 · HAW
Mazor Surgical Technologies , Ltd.
Radiology · 28d
Cleared Aug 26, 2010
SHIMADZU COLLIMATOR R-20J
K101036 · IZX
Shimadzu Corp.
Radiology · 134d
Cleared Aug 24, 2010
METAFLEXCOIL
K101632 · MOS
Neocoil, LLC
Radiology · 75d
Cleared Aug 20, 2010
OSIRIX MD
K101342 · LLZ
Pixmeo Sarl
Radiology · 99d
Cleared Aug 20, 2010
PROCEDURE REHEARSAL STUDIO
K093269 · LLZ
Simbionix , Ltd.
Radiology · 305d
Cleared Aug 19, 2010
STN PROBE
K101816 · ITX
Summit Doppler Systems, Inc.
Radiology · 50d
Cleared Aug 18, 2010
NEONATE ARRAY COILS
K091047 · MOS
Lmt Medical Systems GmbH
Radiology · 492d
Cleared Aug 17, 2010
CURIEPACS (DICOM PACS SOFTWARE)
K102148 · LLZ
Moksha Digital Software Pvt Limited
Radiology · 18d
Cleared Aug 17, 2010
DIGITAL RADIOGRAPHY
K102012 · MQB
Canon Inc. -Medical Equipment Group
Radiology · 32d
Cleared Aug 17, 2010
RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER
K101038 · KPQ
Acceletronics Digital Imaging, LLC
Radiology · 125d