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
5353–5376 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared May 23, 2013
DISCOVERY MR750W 3.0T
K130115 · LNH
Ge Medical Systems, LLC
Radiology · 127d
Cleared May 22, 2013
ANYTHINK PACS WORKSTATION
K131299 · LLZ
Beijing Crealife Technology Co., Ltd.
Radiology · 15d
Cleared May 21, 2013
ALLURA XPER FD OR TABLE SERIES
K130842 · IZI
Philips Medical Systems Nederland B.V.
Radiology · 55d
Cleared May 20, 2013
3T DISTAL COIL, 3T ELBOW COIL, 3T LONG BONE COIL
K130457 · MOS
Resonance Innovations, LLC
Radiology · 87d
Cleared May 20, 2013
NORDIC TUMOREX
K123306 · LLZ
Nordicneurolab
Radiology · 208d
Cleared May 17, 2013
MAGNETOM AVANTO-FIT, MAGNETOM SKYRA-FIT
K130885 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 49d
Cleared May 17, 2013
NEUROQ 3.6
K130451 · KPS
Syntermed, Inc.
Radiology · 84d