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 × Cleared only ×
15,570 results
505–528 of 15,570
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 15, 2025
IsoSphere
K242818 · KXK
Isoaid, LLC
Radiology · 300d
Cleared Jul 14, 2025
PeekMed web
K251096 · QIH
Peek Health, S.A.
Radiology · 95d
Cleared Jul 14, 2025
LUMINOS Q.namix T
K250660 · OWB
Siemens Medical Solutions
Radiology · 131d
Cleared Jul 14, 2025
GECHO
K250120 · LLZ
Narnar, LLC
Radiology · 179d
Cleared Jul 11, 2025
Achieva
K251808 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 29d
Cleared Jul 11, 2025
ULTRASONIC PROBE UM-S20-17S (UM-S20-17S)
K250762 · ITX
Olympus Medical Systems Corporation
Radiology · 120d
Cleared Jul 11, 2025
B-Scan
K243227 · IYO
Accutome, Inc. Doing Business AS...
Radiology · 276d
Cleared Jul 10, 2025
Sonosite LX Ultrasound System
K251830 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 27d
Cleared Jul 10, 2025
Vivid Pioneer
K251169 · IYN
GE Medical Systems Ultrasound and...
Radiology · 86d
Cleared Jul 09, 2025
Cios Alpha
K251520 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 54d
Cleared Jul 08, 2025
TumorSight Viz
K251766 · QIH
SimBioSys, Inc.
Radiology · 29d
Cleared Jul 07, 2025
CustomSurg OrthoPlanner
K251863 · LLZ
Customsurg AG
Radiology · 20d
Cleared Jul 07, 2025
TAVIPILOT
K243884 · OWB
Caranx Medical
Radiology · 201d
Cleared Jul 03, 2025
Biograph Vision PET/CT Systems
K251671 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 34d
Cleared Jul 03, 2025
syngo.via MI Workflows
K251528 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 45d
Cleared Jul 03, 2025
SOMATOM go.Now
K250822 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 107d
Cleared Jul 03, 2025
MammoScreen® (4)
K243679 · QDQ
Therapixel
Radiology · 216d
Cleared Jul 02, 2025
Orthoscan TAU Mini C-Arm
K250587 · OXO
Ziehm-Orthoscan, Inc.
Radiology · 125d
Cleared Jul 02, 2025
Mendaera Guidance System
K250524 · ITX
Mendaera, Inc.
Radiology · 131d
Cleared Jul 02, 2025
Leksell Gamma Knife® (Elekta Esprit)
K250391 · IWB
Elekta Solutions AB
Radiology · 140d
Cleared Jul 01, 2025
StrokeSENS ASPECTS Software Application
K250221 · POK
Circle Cardiovascular Imaging, Inc.
Radiology · 158d
Cleared Jul 01, 2025
Bunkerhill Abdominal Aortic Quantification (AAQ)
K243779 · QIH
BunkerHill Health
Radiology · 204d
Cleared Jun 30, 2025
EchoConfidence (USA)
K250670 · QIH
Mycardium AI Limited
Radiology · 117d
Cleared Jun 30, 2025
PIUR tUS inside
K250484 · QIH
Piur Imaging GmbH
Radiology · 131d