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
4009–4032 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Feb 23, 2017
Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10
K163688 · IYN
Medisono, LLC
Radiology · 57d
Cleared Feb 23, 2017
RSM 1824C with RConsole1
K162670 · MUE
DRTECH Corporation
Radiology · 150d
Cleared Feb 23, 2017
Lung Nodule Assessment and Comparison Option (LNA)
K162484 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 169d
Cleared Feb 22, 2017
Aquarius 8600
K170202 · MQB
Imaging Dynamics Company , Ltd.
Radiology · 30d
Cleared Feb 22, 2017
HS70A Diagnostic Ultrasound System
K163691 · IYN
Samsung Medison Co., Ltd.
Radiology · 56d
Cleared Feb 14, 2017
SIGNA PET/MR
K163619 · OUO
Ge Medical Systems, LLC
Radiology · 54d
Cleared Feb 14, 2017
syngo Application Software
K163285 · LLZ
Siemens Medical Solution USA, Inc.
Radiology · 84d
Cleared Feb 14, 2017
SIS Software
K162830 · LLZ
Surgical Information Sciences, Inc.
Radiology · 130d
Cleared Feb 13, 2017
Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model...
K160610 · JAQ
Kobold, LLC
Radiology · 347d
Cleared Feb 10, 2017
LOGIQ P9 and LOGIQ P7
K163596 · IYN
Ge Healthcare
Radiology · 51d
Cleared Feb 09, 2017
pixium 4343RCE
K170113 · MQB
Philips Medical Systems Dmc GmbH
Radiology · 28d
Cleared Feb 09, 2017
Pinnacle Radiation Therapy Planning System
K170086 · MUJ
Philips Medical Systems (Cleveland),...
Radiology · 30d
Cleared Feb 09, 2017
syngo.CT Extended Functionality
K163341 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 72d
Cleared Feb 09, 2017
syngo. CT Single Source Dual Energy (twin beam)
K163289 · JAK
Siemens Medical Solutions USA, Inc.,...
Radiology · 79d
Cleared Feb 08, 2017
VIVIX-S 1417N
K163703 · MQB
Vieworks Co., Ltd.
Radiology · 41d
Cleared Feb 06, 2017
syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology
K163294 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 76d
Cleared Feb 06, 2017
UC-CARE NaviGo Workstation
K160934 · LLZ
UC-CARE , Ltd.
Radiology · 308d
Cleared Feb 02, 2017
Aquilion Lightning, TSX-036A/1, V8.4
K170019 · JAK
Toshibamedical Systems Corporation
Radiology · 30d
Cleared Jan 31, 2017
Philips CombiDiagnost R90
K163210 · JAA
Philips Medical Systems Dmc GmbH
Radiology · 77d
Cleared Jan 31, 2017
NobelClinician, DTX Studio implant
K163122 · LLZ
Nobel Biocare AB
Radiology · 84d
Cleared Jan 31, 2017
Acclarix LX8 Diagnostic Ultrasound System
K162055 · IYN
Edan Instruments, Inc.
Radiology · 190d
Cleared Jan 27, 2017
nordicBrainEx
K163324 · LLZ
Nordicneurolab AS
Radiology · 63d
Cleared Jan 27, 2017
MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software
K163312 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 65d
Cleared Jan 27, 2017
MAGNETOM Sempra with syngo MR E11S
K163211 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 72d