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
1777–1800 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Oct 31, 2022
CW60N
K222722 · PGY
Wide Corporation
Radiology · 53d
Cleared Oct 31, 2022
CL24N
K222717 · PGY
Wide Corporation
Radiology · 53d
Cleared Oct 28, 2022
Stage
K223079 · LNH
Spintech, Inc.
Radiology · 28d
Cleared Oct 28, 2022
Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20,...
K222191 · IYN
Supersonic Imagine
Radiology · 98d
Cleared Oct 27, 2022
uMR Omega with uWS-MR-MRS
K220332 · LNH
Shanghai United Imaging Healthcare...
Radiology · 265d
Cleared Oct 26, 2022
DigiX FDX
K223060 · KPR
Allengers Medical Systems Limited
Radiology · 26d
Cleared Oct 26, 2022
EzRay Air 2 Wall (Model: VEX-S350W)
K223058 · EHD
VATECH Co., Ltd.
Radiology · 26d