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
3385–3408 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 07, 2018
Multi Modality Viewer
K182230 · LLZ
Vital Images, Inc.
Radiology · 21d
Cleared Sep 07, 2018
syngo.via View&GO (Version VA10A)
K182208 · LLZ
Siemens Healthcare GmbH
Radiology · 23d
Cleared Sep 07, 2018
CTXX85
K182147 · JAK
Analogic Corporation
Radiology · 30d
Cleared Sep 07, 2018
Solstice SRS Immobilization System
K182079 · IYE
Medtec Inc. Dba Civco Medical Solutions
Radiology · 36d
Cleared Sep 07, 2018
mediCAD 4.0
K170702 · LLZ
Medicad Hectec GmbH
Radiology · 548d
Cleared Sep 06, 2018
Optima XR240amx
K182234 · IZL
Ge Medical Systems, LLC
Radiology · 20d
Cleared Sep 06, 2018
Ultrasound System SONIMAGE HS1
K182153 · IYO
Konica Minolta, Inc.
Radiology · 29d
Cleared Sep 05, 2018
Precise Treatment System
K182138 · IYE
Eleckta Limited
Radiology · 29d
Cleared Aug 31, 2018
AmCAD-UT Detection 2.2
K180006 · LLZ
Amcad Biomed Corporation
Radiology · 241d
Cleared Aug 29, 2018
Change Healthcare Enterprise Viewer
K181185 · LLZ
Change Healthcare Canada Company
Radiology · 118d
Cleared Aug 27, 2018
BenQ Diagnostic Ultrasound System
K181313 · IYN
Qisda Corporation
Radiology · 102d
Cleared Aug 24, 2018
RadiForce GX560, GX560-AR
K181609 · PGY
Eizo Corporation
Radiology · 66d
Cleared Aug 17, 2018
PreXion 3D Excelsior
K181983 · OAS
Prexion Corporation
Radiology · 23d
Cleared Aug 17, 2018
SmartPerfusion
K181966 · OWB
Philips Medical Systems Nederlands B.V.
Radiology · 25d
Cleared Aug 17, 2018
OSCAR (OSCAR Prime, OSCAR Classic)
K181943 · OWB
Genoray Co., Ltd.
Radiology · 28d
Cleared Aug 17, 2018
Cios Select
K181767 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 45d
Cleared Aug 17, 2018
CBit Series Digital Color Doppler Ultrasound System
K180974 · IYN
CHISON Medical Technologies Co., Ltd.
Radiology · 126d
Cleared Aug 16, 2018
IGTFusion
K180522 · LLZ
Igi Technologies
Radiology · 170d
Cleared Aug 16, 2018
NeuroQ 3.8
K180077 · KPS
Syntermed
Radiology · 218d
Cleared Aug 15, 2018
Mini Ridge Filter and auxiliary functions for PROBEAT-V
K181676 · LHN
Hitachi Ltd. Healthcare Hitachi Works
Radiology · 51d
Cleared Aug 15, 2018
Artis zee/zeego & Artis Q/Q.zen
K181407 · OWB
Siemens Medical Solution USA, Inc.
Radiology · 77d
Cleared Aug 14, 2018
uCT 530, uCT 550
K181414 · JAK
Shanghai United Imaging Healthcare...
Radiology · 76d
Cleared Aug 13, 2018
Vantage Galan 3T, MRT-3020/A7, V5.0
K181593 · LNH
Canon Medical Systems Corporation
Radiology · 56d
Cleared Aug 13, 2018
ONIS-PACS
K181318 · LLZ
Digitalcore Co., Ltd.
Radiology · 87d