FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,589 results
985–1008 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 26, 2024
TRIDENT Mobile Fluoroscopy System
K233380 · JAA
Dornier Medtech America
Radiology · 268d
Cleared Jun 25, 2024
VEA Align
K240582 · QIH
Eos Imaging
Radiology · 116d
Cleared Jun 21, 2024
V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System
K240631 · IYN
Samsung Medison Co., Ltd.
Radiology · 107d
Cleared Jun 21, 2024
O-arm O2 Imaging System
K240465 · OWB
Medtronic Navigation, Inc.
Radiology · 126d
Cleared Jun 21, 2024
See Factor CT3™
K233230 · OWB
Epica International, Inc.
Radiology · 267d
Cleared Jun 21, 2024
Medihub Prostate
K233196 · QIH
JLK, Inc.
Radiology · 267d
Cleared Jun 20, 2024
SMART Bun-Yo-Matic CT
K240642 · QIH
Disior, Ltd.
Radiology · 106d
Cleared Jun 17, 2024
Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9...
K240684 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 97d
Cleared Jun 17, 2024
MediOMx
K233331 · LLZ
Pmx, Inc.
Radiology · 262d
Cleared Jun 14, 2024
SIS System
K241083 · QIH
Surgical Information Sciences, Inc.
Radiology · 56d
Cleared Jun 14, 2024
Clarius OB AI
K233955 · IYN
Clarius Mobile Health Corp.
Radiology · 182d
Cleared Jun 13, 2024
21.3” 5MP Color LCD Display UMD5-21B01
K241499 · PGY
Acula Technology Corp.
Radiology · 16d
Cleared Jun 13, 2024
Relu Creator
K233925 · QIH
Relu BV
Radiology · 183d
Cleared Jun 13, 2024
Radiography 7300 C
K233662 · KPR
Philips Medical Systems Dmc GmbH
Radiology · 211d
Cleared Jun 12, 2024
RS85 Diagnostic Ultrasound System
K240516 · IYN
Samsung Medison Co., Ltd.
Radiology · 110d
Cleared Jun 12, 2024
ACUSON SC2000 Diagnostic Ultrasound System
K233613 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 212d
Cleared Jun 12, 2024
ACUSON P500 Ultrasound System
K233610 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 212d
Cleared Jun 10, 2024
Venue Sprint
K240206 · IYN
GE Medical Systems Ultrasound and...
Radiology · 137d
Cleared Jun 10, 2024
Venue
K240111 · IYN
GE Medical Systems Ultrasound and...
Radiology · 146d
Cleared Jun 10, 2024
Venue Go
K240053 · IYN
GE Medical Systems Ultrasound and...
Radiology · 154d
Cleared Jun 10, 2024
Venue Fit
K234106 · IYN
GE Medical Systems Ultrasound and...
Radiology · 167d
Cleared Jun 10, 2024
OmniTom Elite
K233767 · JAK
Neurologica Corporation
Radiology · 199d
Cleared Jun 07, 2024
iLoop Interventional Coil 0.55T
K241069 · MOS
Noras Mri Products GmbH
Radiology · 49d
Cleared Jun 07, 2024
Cardiac CT Function Software Application
K241038 · QIH
Circle Cardiovascular Imaging
Radiology · 52d