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
5449–5472 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 02, 2013
SYNGO.CT NEURO PERFUSION
K123541 · JAK
Siemens Medical Systems, Inc.
Radiology · 134d
Cleared Apr 02, 2013
INTUITION
K121916 · LLZ
Terarecon,Inc.
Radiology · 274d
Cleared Mar 29, 2013
SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM
K123509 · JAK
Hitachi Medical Systems America, Inc.
Radiology · 136d
Cleared Mar 28, 2013
5MP MONOCHROME LCD MONITOR, RADIFORCE GX540
K130336 · LLZ
Eizo Nanao Corporation
Radiology · 45d
Cleared Mar 28, 2013
1.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUM
K123272 · MOS
Neocoil, LLC
Radiology · 160d
Cleared Mar 26, 2013
NOBELCLINICIAN
K123976 · LLZ
Nobel Biocare AB
Radiology · 90d
Cleared Mar 25, 2013
ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM
K130754 · IYN
Siemens Medi Cal Solutions, Inc.
Radiology · 6d
Cleared Mar 25, 2013
SONOSITE MAXX SERIES ULTRASOUND SYSTEM
K130173 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 60d
Cleared Mar 21, 2013
ACUSON S1000 DIAGNOSTIC ULTRASOUND SYSTEM
K130619 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 14d
Cleared Mar 21, 2013
ALLURA 3D-RA REL 6, 3D ROADMAP REL 1, MR-CT ROADMAP REL 1
K121772 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 279d
Cleared Mar 20, 2013
MIRADA RTX
K130393 · LLZ
Mirada Medical, Ltd.
Radiology · 33d
Cleared Mar 20, 2013
PENTAX EG-3870UTK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS
K130247 · ODG
Pentax of America, Inc.
Radiology · 47d
Cleared Mar 20, 2013
PALM BLADDER SCANNER
K130229 · IYO
Mianyang Meike Electronic Equipment...
Radiology · 50d
Cleared Mar 20, 2013
SUITEHEART
K130228 · LLZ
Neosoft, LLC
Radiology · 50d
Cleared Mar 20, 2013
PENTAX EG-3670URK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS
K130206 · ODG
Pentax of America, Inc.
Radiology · 51d
Cleared Mar 15, 2013
GALILEOS FAMILY
K123070 · OAS
Sirona Dental Systems GmbH
Radiology · 165d
Cleared Mar 15, 2013
RAYSCAN A-EXPERT
K122918 · MUH
Ray Co., Ltd.
Radiology · 172d
Cleared Mar 14, 2013
RESOLUTIONMD MOBILE 3.1 MODEL RMD-MOB-31
K123186 · LLZ
Calgary Scientific, Inc.
Radiology · 154d
Cleared Mar 13, 2013
ESOPHAGUS BOUGIE SET
K130251 · JAQ
Varian Medical Systems, Inc.
Radiology · 40d
Cleared Mar 13, 2013
OPTIMA MR450W
K123522 · LNH
Ge Healthcare (Ge Medical Systems, LLC)
Radiology · 118d
Cleared Mar 12, 2013
SYNGO, CT BONE READING
K123584 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 111d
Cleared Mar 12, 2013
DIGITAL FLAT PANEL X-RAY DETECTOR / 1012WCA
K123345 · MQB
Rayence Co., Ltd.
Radiology · 132d
Cleared Mar 12, 2013
RAYSCAN A-EXPERT 3D
K122981 · OAS
Ray Co., Ltd.
Radiology · 169d
Cleared Mar 11, 2013
STEREOS WORKSTATION
K130395 · LLZ
Eos Imaging, Inc.
Radiology · 24d