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
5377–5400 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 14, 2013
EMORY CARDIAC TOOLBOX 3.2
K130902 · KPS
Syntermed, Inc.
Radiology · 74d
Cleared Jun 14, 2013
DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
K130801 · IYN
Sonoscape Company Limited
Radiology · 84d
Cleared Jun 14, 2013
SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS
K130542 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 105d
Cleared Jun 14, 2013
I-MAX TOUCH 3D
K130443 · OAS
Owandy
Radiology · 113d
Cleared Jun 14, 2013
CHABNER XRT GARMENTS
K121284 · IYE
Chabner Xrt, LLC
Radiology · 410d
Cleared Jun 11, 2013
NON-PYROGENIC ULTRASOUND TRANSDUCER COVER
K131528 · ITX
CIVCO Medical Instruments Co., Inc.
Radiology · 14d
Cleared Jun 11, 2013
DR LONG LENGTH IMAGING SOFTWARE
K130567 · MQB
Carestream Health, Inc.
Radiology · 99d
Cleared Jun 11, 2013
MAMMOMAT INSPIRATION PRIME
K123520 · MUE
Siemens Medical Solutions USA, Inc.
Radiology · 208d
Cleared Jun 07, 2013
ISR'OBOT MONA LISA
K130944 · IYO
Biobot Surgical Pte., Ltd.
Radiology · 64d
Cleared Jun 07, 2013
TELERADPRO EDGE
K130636 · LMA
Vidar Systems Corp.
Radiology · 88d
Cleared Jun 07, 2013
CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTOR
K130464 · MQB
Carestream Health, Inc.
Radiology · 105d
Cleared Jun 07, 2013
IMR SOFTWARE APPLICATION
K123576 · JAK
Philips Healthcare (Cleveland)
Radiology · 199d
Cleared Jun 07, 2013
XGEO GU60
K123105 · KPR
Samsung Electronics Co., Ltd.
Radiology · 248d
Cleared Jun 06, 2013
ACUSON S2000 AND S3000 DIAGNOSTIC ULTRASOUND SYSTEMS
K130739 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 80d
Cleared Jun 06, 2013
AQUILION PRIME, V5.00
K130645 · JAK
Toshibamedical Systems Corporation
Radiology · 87d
Cleared May 31, 2013
PHT-6500, PHT-60CFO
K130432 · OAS
VATECH Co., Ltd.
Radiology · 99d
Cleared May 31, 2013
SINGLE ENERGY (SE) FEMUR EXAMS
K130277 · KGI
Hologic, Inc.
Radiology · 116d
Cleared May 29, 2013
ETIAM PACS COMPONENTS
K131392 · LLZ
Etiam S.A.S.U.
Radiology · 15d
Cleared May 29, 2013
NIO COLOR 3MP LED
K131295 · LLZ
Barco N.V.
Radiology · 23d
Cleared May 29, 2013
SCANORA 3DX
K130297 · OAS
Palodex Group OY
Radiology · 112d
Cleared May 29, 2013
MR PERMEABILITY
K130278 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 113d
Cleared May 24, 2013
CORONIS 3MP
K131246 · LLZ
Barco N.V.
Radiology · 23d
Cleared May 24, 2013
TERASON USMART3200T ULTRASOUND SYSTEM
K131209 · IYN
Teratech Corp.
Radiology · 25d
Cleared May 24, 2013
PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
K131088 · IYN
Sonoscape Company Limited
Radiology · 36d