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
769–792 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 19, 2025
EXPD 4343N1
K243443 · MQB
DRTECH Corporation
Radiology · 133d
Cleared Mar 18, 2025
Lux HD 35 Detector (Lux HD 35)
K243556 · MQB
Iray Imaging Technology (Haining)...
Radiology · 120d
Cleared Mar 18, 2025
QP-Prostate® CAD
K242683 · QDQ
Quibim S.L.
Radiology · 193d
Cleared Mar 18, 2025
Radlink GPS Pro Imaging
K242161 · LLZ
Radlink, Inc.
Radiology · 237d
Cleared Mar 18, 2025
Klarity SGRT System (ARSG-E1A, ARSG-E3A)
K241937 · IYE
Klarity Medical & Equipment (GZ) Co.,...
Radiology · 259d
Cleared Mar 17, 2025
SIGNA Prime Elite
K250379 · LNH
Ge Medical Systems, LLC
Radiology · 34d
Cleared Mar 17, 2025
LVivo Software Application
K243862 · QIH
Dia Imaging Analysis, Ltd.
Radiology · 91d
Cleared Mar 17, 2025
Ziehm Solo FD
K243646 · OWB
Ziehm Imaging GmbH
Radiology · 111d
Cleared Mar 17, 2025
SERV MEDICAL CDSS
K241975 · LLZ
Serv Medical Pte., Ltd.
Radiology · 255d
Cleared Mar 14, 2025
BodyTom 64
K242811 · JAK
Neurologica Corporation, A Subsidiary...
Radiology · 177d
Cleared Mar 14, 2025
PLANET Onco Dose (3.2)
K241765 · LLZ
Dosisoft SA
Radiology · 267d
Cleared Mar 13, 2025
Ziehm Vision FD
K243735 · OWB
Ziehm Imaging GmbH
Radiology · 99d
Cleared Mar 12, 2025
RCT600
K243903 · OAS
Ray Co., Ltd.
Radiology · 83d
Cleared Mar 12, 2025
2430TCA with Xmaru W
K243849 · MUE
Rayence Co., Ltd.
Radiology · 86d
Cleared Mar 11, 2025
Better Diagnostics Caries Assist (BDCA) Version 1.0
K241725 · MYN
Better Diagnostics AI Corp.
Radiology · 270d
Cleared Mar 07, 2025
Cleerly LABS (v2.0)
K242338 · QIH
Cleerly, Inc.
Radiology · 212d
Cleared Mar 06, 2025
LVivo Seamless
K243331 · QIH
Dia Imaging Analysis, Ltd.
Radiology · 133d
Cleared Mar 05, 2025
Prostate MR AI (VA10A)
K241770 · QDQ
Siemens Healthcare GmbH
Radiology · 258d
Cleared Mar 04, 2025
Ceevra Reveal 3+
K243933 · QIH
Ceevra, Inc.
Radiology · 74d
Cleared Mar 03, 2025
Titanium Flexible Geometry FSD Applicator Set (GM11013400)
K243939 · JAQ
Varian Medical Systems, Inc.
Radiology · 73d
Cleared Mar 03, 2025
HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and...
K243881 · KPS
Bracco Diagnostics, Inc.
Radiology · 75d
Cleared Mar 03, 2025
JLK-SDH
K243611 · QAS
JLK, Inc.
Radiology · 101d
Cleared Mar 03, 2025
LVivo Software Application
K243235 · QIH
Dia Imaging Analysis, Ltd.
Radiology · 144d
Cleared Feb 28, 2025
16ch Flex SPEEDER Medium 1.5T (Q7000246)
K244054 · MOS
Quality Electrodynamics
Radiology · 59d