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
217–240 of 15,570
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 10, 2026
myray ProXIma X6
K252353 · OAS
Cefla S.C.
Radiology · 224d
Cleared Mar 09, 2026
LiverMultiScan (v6.0)
K253413 · LNH
Perspectum, Ltd.
Radiology · 159d
Cleared Mar 06, 2026
Bunkerhill Contrast AVC
K260167 · JAK
BunkerHill Health
Radiology · 45d
Cleared Mar 06, 2026
Bunkerhill Contrast CAC
K260166 · JAK
BunkerHill Health
Radiology · 45d
Cleared Mar 06, 2026
VELYS™ Hip Navigation
K253551 · QIH
Depuy Ireland UC
Radiology · 112d
Cleared Mar 05, 2026
AV Cardiac CT
K260169 · JAK
Philips Medical Systems Nederland B.V.
Radiology · 44d
Cleared Mar 05, 2026
CEPHX3D
K252538 · QIH
Orca Dental AI , Ltd.
Radiology · 205d
Cleared Mar 05, 2026
Magnifico Open (100009900)
K251901 · LNH
Esaote, S.P.A.
Radiology · 258d
Cleared Mar 04, 2026
QT Scanner 2000 Model A
K253898 · IYO
QT Imaging Holdings, Inc.
Radiology · 89d
Cleared Mar 03, 2026
Annalise Enterprise
K253818 · QAS
Harrison-AI Medical Pty, Ltd.
Radiology · 95d
Cleared Mar 03, 2026
SOTA Cloud Smart Sensor (1.5)
K251793 · MUH
Sota Cloud Corp.
Radiology · 265d
Cleared Mar 02, 2026
Clarius Ejection Fraction AI
K253593 · QIH
Clarius Mobile Health Corp.
Radiology · 105d
Cleared Feb 27, 2026
Ligence Heart
K253535 · QIH
Ligence Uab
Radiology · 106d
Cleared Feb 26, 2026
BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax
K253578 · QAS
Aidoc Medical , Ltd.
Radiology · 101d
Cleared Feb 24, 2026
AI Platform 2.2 (AIP002)
K260217 · QIH
Exo Imaging
Radiology · 32d
Cleared Feb 23, 2026
MAGNETOM Flow.Ace
K260265 · LNH
Siemens Shenzhen Magnetic Resonance ,...
Radiology · 26d
Cleared Feb 23, 2026
Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal...
K253648 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 95d
Cleared Feb 23, 2026
SKIA-Head (Model: SKIA-ST00)
K253486 · LLZ
Skia, Inc.
Radiology · 129d
Cleared Feb 23, 2026
AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)
K253244 · IZL
Poskom Co., Ltd.
Radiology · 147d
Cleared Feb 20, 2026
CARA System
K252500 · OWB
Cara Medical, Ltd.
Radiology · 196d
Cleared Feb 19, 2026
TrueFit Bolus
K260308 · MUJ
Adaptiiv Medical Technologies, Inc.
Radiology · 20d
Cleared Feb 19, 2026
AS Software Version Asera
K260205 · LLZ
AS Software, LLC
Radiology · 27d
Cleared Feb 19, 2026
Portable Dental X-ray Device (GT-1)
K254018 · EHD
Guilin Refine Medical Instrument Co.,...
Radiology · 66d
Cleared Feb 19, 2026
Monaco RTP System (6.3)
K252002 · MUJ
Elekta Solutions AB
Radiology · 237d