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
2305–2328 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 21, 2021
Rover
K211423 · IZL
Micro-X Limited
Radiology · 14d
Cleared May 21, 2021
Universal Viewer
K211312 · LLZ
Ge Healthcare
Radiology · 21d
Cleared May 20, 2021
C-Qual M™ Breastboard
K211001 · IYE
Medtec, Inc. Dba Civco Medical...
Radiology · 48d
Cleared May 20, 2021
Xoran Workstation, Model 10050
K210257 · LLZ
Xoran Technologies, LLC
Radiology · 108d
Cleared May 19, 2021
Vereos PET/CT
K210880 · KPS
Philips Medical Systems Nederland B.V.
Radiology · 56d
Cleared May 19, 2021
CINA CHEST
K210237 · QAS
Avicenna.Ai
Radiology · 111d
Cleared May 19, 2021
Overjet Dental Assist
K210187 · LLZ
Overjet, Inc.
Radiology · 114d
Cleared May 17, 2021
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
K211037 · LNH
Canon Medical Systems Corporation
Radiology · 40d
Cleared May 17, 2021
Cercare Medical Neurosuite
K202793 · LLZ
Cercare Medical Aps
Radiology · 237d
Cleared May 14, 2021
HOLOSCOPE-i
K210072 · LLZ
Real View Imaging , Ltd.
Radiology · 123d
Cleared May 14, 2021
Klarity Bolus
K202747 · IYE
Klarity Medical & Equipment (GZ) Co.,...
Radiology · 235d
Cleared May 13, 2021
SIGNA 7.0T
K211118 · LNH
Ge Medical Systems, LLC
Radiology · 28d
Cleared May 13, 2021
HS40 Diagnostic Ultrasound System
K210426 · IYN
Samsung Medison Co., Ltd.
Radiology · 91d
Cleared May 12, 2021
Symbia VA10A Family
K210557 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 76d
Cleared May 06, 2021
Corvus Radiation Therapy Planning System
K211034 · MUJ
Best Nomos
Radiology · 29d
Cleared May 06, 2021
ImagePilot
K210066 · LLZ
Konica Minolta, Inc.
Radiology · 115d
Cleared May 04, 2021
SOTA Cloud Imaging
K210682 · LLZ
Sota Precision Optics, Inc. Dba Sota...
Radiology · 57d
Cleared May 04, 2021
PtoleMedic System
K202521 · LLZ
Lento Medical Innovation, Inc.
Radiology · 245d
Cleared Apr 30, 2021
AcuityDRe
K210919 · MQB
Radmedix, LLC
Radiology · 32d
Cleared Apr 30, 2021
HYPER AiR
K210001 · KPS
Shanghai United Imaging Healthcare...
Radiology · 116d
Cleared Apr 30, 2021
syngo. CT Extended Functionalities
K203699 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 133d
Cleared Apr 28, 2021
1717FCC
K210985 · MQB
Rayence Co., Ltd.
Radiology · 27d
Cleared Apr 28, 2021
AMX Navigate
K210982 · IZL
Ge Medical Systems, LLC
Radiology · 27d
Cleared Apr 28, 2021
Trinias
K203535 · OWB
Shimadzu Corporation Medical Systems
Radiology · 146d