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
2329–2352 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 09, 2021
Vivid S60N / Vivid S70N
K211216 · IYN
GE Medical Systems Ultrasound and...
Radiology · 47d
Cleared Jun 09, 2021
Palm Bladder Scanner - PBSV7.1
K210591 · IYO
Mianyang Meike Electronic Equipment...
Radiology · 100d
Cleared Jun 04, 2021
Micro C Medical Imaging System, M01
K211473 · IZL
Oxos Medical, Inc.
Radiology · 23d
Cleared Jun 04, 2021
Prudent 1717, Prudent 1417, Prudent 1212
K211108 · MQB
Pixxgen Corporation
Radiology · 51d
Cleared Jun 02, 2021
Transpara 1.7.0
K210404 · QDQ
Screenpoint Medical B.V.
Radiology · 112d
Cleared May 27, 2021
ZedView
K200704 · LLZ
Lexi Co., Ltd.
Radiology · 435d
Cleared May 26, 2021
Breast Volume Navigator (BVN) Model G-2000
K211098 · IYO
Metritrack, Inc.
Radiology · 43d
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