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
2329–2352 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Aug 03, 2021
Remex KA6
K212144 · IZL
Remedi Co., Ltd.
Radiology · 25d
Cleared Aug 02, 2021
DynaCAD
K212175 · LLZ
Invivo Corporation
Radiology · 21d
Cleared Aug 02, 2021
breastscape v1.0
K211431 · QIH
Olea Medical
Radiology · 87d
Cleared Jul 30, 2021
FibroScan 230
K212035 · IYO
Echosens
Radiology · 30d
Cleared Jul 30, 2021
DX-D Imaging Package with XD Detectors
K211790 · MQB
Agfa N.V.
Radiology · 50d
Cleared Jul 30, 2021
syngo.via RT Image Suite
K211379 · MUJ
Siemens Medical Solutions USA, Inc.
Radiology · 87d
Cleared Jul 30, 2021
qER-Quant
K211222 · QIH
Qure.Ai Technologies
Radiology · 98d
Cleared Jul 30, 2021
Labat series Diagnostic Ultrasound System
K210154 · IYN
Shenzhen Wisonic Medical Technology...
Radiology · 190d
Cleared Jul 29, 2021
Zap-X Radiosurgical System
K211663 · IYE
Zap Surgical Systems, Inc.
Radiology · 58d
Cleared Jul 29, 2021
CRUXVIEW
K211317 · MUH
Cruxell Corp.
Radiology · 90d
Cleared Jul 28, 2021
Portray
K211014 · EHD
Surround Medical Systems
Radiology · 114d
Cleared Jul 27, 2021
ClariCT.AI
K212074 · LLZ
Claripi, Inc.
Radiology · 25d
Cleared Jul 27, 2021
aPROMISE
K211655 · LLZ
Exini Diagnostics AB
Radiology · 60d
Cleared Jul 27, 2021
Volpara Imaging Software
K211279 · LLZ
Volpara Health Technologies Limited
Radiology · 91d
Cleared Jul 27, 2021
PET VCAR
K211247 · KPS
GE Medical Systems SCS
Radiology · 92d
Cleared Jul 27, 2021
Us2.v1
K210791 · QIH
Eko.Ai Pte Ltd. D/B/A Us2.Ai
Radiology · 133d
Cleared Jul 27, 2021
Insight Agile DRF
K210469 · JAA
Imaging Engineering, LLC
Radiology · 161d
Cleared Jul 23, 2021
MySpine WebPlanner & MyBalance
K211386 · LLZ
Medacta International S.A.
Radiology · 79d
Cleared Jul 23, 2021
SC1 Handheld Ultrasound Imaging System (Model: SC1)
K210468 · IYO
Fcu Co., Ltd.
Radiology · 157d
Cleared Jul 22, 2021
ExacTrac Dynamic
K211939 · IYE
Brainlab AG
Radiology · 29d
Cleared Jul 22, 2021
DC-Air and Athlos-1 and Athlos-Air
K211688 · MUH
Athlos OY
Radiology · 50d
Cleared Jul 22, 2021
Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit...
K211633 · LNH
Canon Medical Systems Corporation
Radiology · 56d
Cleared Jul 22, 2021
QSM software, QSMetric
K210415 · LNH
Medimagemetric, LLC
Radiology · 161d
Cleared Jul 22, 2021
syngo.CT Skull Unfolding
K203411 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 245d