Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Radiology ×
15,695 results
2401–2424 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 10, 2021
syngo.via MI WorkFlows, Scenium, syngo MBF
K211459 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Jun 10, 2021
Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9...
K210699 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 93d
Cleared Jun 10, 2021
M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9...
K210416 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 119d
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