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
433–456 of 15,570
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 05, 2025
ViewMate™ Multi Ultrasound System (VMM-ICE-01)
K251250 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 135d
Cleared Sep 05, 2025
3D-SHAPER
K251022 · KGI
3D-Shaper Medical S.L
Radiology · 156d
Cleared Sep 04, 2025
Careverse CoronaryDoc (Careverse CoronaryDoc)
K251656 · QIH
Careverse Technology Pte. , Ltd.
Radiology · 97d
Cleared Sep 04, 2025
Rapid Obstructive Hydrocephalus, Rapid OH
K251533 · QAS
Ischemaview, Inc.
Radiology · 108d
Cleared Sep 04, 2025
Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )
K251438 · EHD
Guilin Woodpecker Medical Instrument...
Radiology · 118d
Cleared Sep 04, 2025
Image Suite
K251168 · LLZ
Carestream Health, Inc.
Radiology · 142d
Cleared Sep 04, 2025
Dose+ (1.0)
K250064 · MUJ
Mvision AI OY
Radiology · 237d
Cleared Sep 03, 2025
Tempus Pixel
K252539 · QIH
Arterys, Inc.
Radiology · 22d
Cleared Sep 03, 2025
AquaCast Mask
K252174 · IYE
Blessing Cathay Corporation
Radiology · 54d
Cleared Sep 02, 2025
OsteoSight™ Hip (v1)
K251408 · SAO
Naitive Technologies, Ltd.
Radiology · 119d
Cleared Sep 02, 2025
VELMENI for DENTISTS (V4D)
K250753 · MYN
Velmeni, Inc.
Radiology · 174d
Cleared Aug 29, 2025
Sonosite LX and Sonosite PX Ultrasound Systems
K251106 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 140d
Cleared Aug 29, 2025
SurgiTwin
K250290 · LLZ
Twinsight
Radiology · 210d
Cleared Aug 29, 2025
PRAEVAorta®2
K243859 · QIH
Nurea
Radiology · 256d
Cleared Aug 28, 2025
RadiForce GX570
K252030 · PGY
Eizo Corporation
Radiology · 59d
Cleared Aug 28, 2025
CT:VQ
K251484 · JAK
4Dmedical Limited
Radiology · 106d
Cleared Aug 28, 2025
Definium Tempo Select
K250788 · KPR
Ge Hualun Medical Systems Co. , Ltd.
Radiology · 167d
Cleared Aug 27, 2025
VistaSoft 4.0 and VisionX 4.0
K250947 · QIH
Durr Dental SE
Radiology · 152d
Cleared Aug 26, 2025
Rapid DeltaFuse
K252526 · LLZ
Ischemaview, Inc.
Radiology · 15d
Cleared Aug 26, 2025
Brainomix 360 Triage Stroke
K251983 · QAS
Brainomix Limited
Radiology · 60d
Cleared Aug 25, 2025
Neurovascular Insight V1.0
K243680 · LLZ
Olea Medical S.A.S.
Radiology · 269d
Cleared Aug 22, 2025
GBrain MRI
K252362 · QIH
Galileo Cds, Inc.
Radiology · 24d
Cleared Aug 22, 2025
PROMO
K251443 · IZL
DRGEM Corporation
Radiology · 105d
Cleared Aug 22, 2025
Diagnostic Ultrasound System (MX7)
K251192 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 127d