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 × Cleared only ×
15,676 results
2377–2400 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 25, 2021
Apache Ultrasound System
K211232 · IYN
Aco Healthcare Co., Ltd.
Radiology · 63d
Cleared Jun 25, 2021
BD Prevue II Peripheral Vascular Vascular Access System
K211193 · IYO
Bard Access Systems, Inc. (C.R. Bard,...
Radiology · 65d
Cleared Jun 25, 2021
Vu-Path Ultrasound System
K203657 · IYN
Crystalline Medical
Radiology · 192d
Cleared Jun 24, 2021
THD Procto Software System
K211623 · IYO
Thd Spa
Radiology · 29d
Cleared Jun 24, 2021
Virtual C DRF Digital Imaging System
K211191 · OWB
Portavision Medical, LLC
Radiology · 64d
Cleared Jun 24, 2021
RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System
K210959 · IYN
Samsung Medison Co., Ltd.
Radiology · 85d
Cleared Jun 22, 2021
SenoBright HD
K211215 · MUE
Ge Healthcare
Radiology · 60d
Cleared Jun 22, 2021
MICROMATE
K203720 · JAK
Isys Medizintechnik GmbH
Radiology · 183d
Cleared Jun 21, 2021
2430MCA with Xmaru W
K202902 · MUE
Rayence Co., Ltd.
Radiology · 265d
Cleared Jun 17, 2021
Precise Position
K203514 · JAK
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 199d
Cleared Jun 16, 2021
Qmenta Care Platform Family
K202718 · LLZ
Mint Labs, Inc., D/B/A. Qmenta
Radiology · 272d
Cleared Jun 11, 2021
Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD
K210500 · IYE
Elekta Limited
Radiology · 109d
Cleared Jun 10, 2021
Fiducial Marker
K211590 · IYE
Carbon Medical Technologies, Inc.
Radiology · 17d
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