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
1705–1728 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 22, 2022
AccuCTP
K220663 · LLZ
ArteryFlow Technology Co., Ltd.
Radiology · 260d
Cleared Nov 21, 2022
SIS System (Version 5.6.0)
K223032 · QIH
Surgical Information Sciences, Inc.
Radiology · 53d
Cleared Nov 21, 2022
SM-V
K222951 · IZL
Sedecal., Sa.
Radiology · 55d
Cleared Nov 18, 2022
EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG
K223124 · MQB
DRTECH Corporation
Radiology · 46d
Cleared Nov 18, 2022
BriefCase
K221330 · QAS
Aidoc Medical , Ltd.
Radiology · 196d
Cleared Nov 17, 2022
SKR 3000
K223267 · MQB
Konica Minolta, Inc.
Radiology · 24d
Cleared Nov 17, 2022
OmegaAI Image Viewer
K222476 · LLZ
Ramsoft, Inc.
Radiology · 93d
Cleared Nov 17, 2022
Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D
K222208 · PGY
Qingdao Hisense Medical Equipment...
Radiology · 115d
Cleared Nov 17, 2022
Multitom Rax
K221281 · OWB
Siemens Medical Solutions
Radiology · 198d
Cleared Nov 16, 2022
BoneMRI v1.4
K221762 · QIH
Mrlguidance B.V.
Radiology · 152d
Cleared Nov 14, 2022
uPMR 790
K222540 · OUO
Shanghai United Imaging Healthcare...
Radiology · 84d
Cleared Nov 14, 2022
Syngo Dynamics (Version VA40F)
K222428 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 95d
Cleared Nov 11, 2022
ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System
K220983 · IYN
Imsonic Medical China, Inc.
Radiology · 221d
Cleared Nov 10, 2022
Synapse 3D Base Tools v6.6
K221677 · LLZ
Fujifilm Corporation
Radiology · 154d
Cleared Nov 10, 2022
AVIEW RT ACS
K220408 · QKB
Coreline Soft Co., Ltd.
Radiology · 269d
Cleared Nov 09, 2022
ViewMate Multi Ultrasound System
K222754 · IYN
Shenzhen Mindray Bio-Meidcal...
Radiology · 58d
Cleared Nov 09, 2022
Exo Iris (El2001)
K222198 · IYN
Exo Imaging, Inc.
Radiology · 110d
Cleared Nov 09, 2022
GammaTile
K221539 · KXK
Gt Medical Technologies
Radiology · 166d
Cleared Nov 08, 2022
Hisense LCD monitor HMD2G21S, HMD3G21S
K222132 · PGY
Qingdao Hisense Medical Equipment...
Radiology · 112d
Cleared Nov 08, 2022
EFAI ChestSuite XR Pneumothorax Assessment System
K221552 · QFM
Ever Fortune.Ai, Co., Ltd.
Radiology · 161d
Cleared Nov 04, 2022
VHA Radiotherapy Bolus
K222639 · IXI
Vha Dean
Radiology · 64d
Cleared Nov 01, 2022
Combined High Frequency X-ray Source
K222258 · IZL
Suzhou Powersite Electric Co., Ltd.
Radiology · 97d
Cleared Nov 01, 2022
Dolphin Blue Imaging
K221478 · LLZ
Patterson Dental Supply, Inc.
Radiology · 162d
Cleared Nov 01, 2022
Klarity SRS Baseplate, Klarity Promise Baseplate
K220539 · IYE
Klarity Medical & Equipment (GZ) Co.,...
Radiology · 249d