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
1777–1800 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 22, 2022
CINA
K221716 · QAS
Avicenna.Ai
Radiology · 162d
Cleared Nov 22, 2022
Avenda Health AI Prostate Cancer Planning Software
K221624 · POK
Avenda Health, Inc.
Radiology · 169d
Cleared Nov 22, 2022
Minimally Invasive Prostate Surgery Navigation System
K221499 · LLZ
Augment Intelligent Medical System...
Radiology · 183d
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