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
337–360 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Feb 13, 2026
uMI Panvivo (uMI Panvivo)
K253564 · KPS
Shanghai United Imaging Healthcare...
Radiology · 88d
Cleared Feb 11, 2026
Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona...
K253049 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 142d
Cleared Feb 11, 2026
AI4CMR v2.0
K252084 · QIH
Ai4medimaging Medical Solutions S.A.
Radiology · 224d
Cleared Feb 11, 2026
ArmSure Fluoroscopic Positioning System
K251992 · OWB
Savfe Co. , Ltd.
Radiology · 229d
Not Cleared Feb 11, 2026
Delivery Date AI
DEN250007 · SHE
Ultrasound AI
Radiology · 331d
Cleared Feb 10, 2026
SpaceOAR Vue System (SV-2101)
K260119 · OVB
Boston Scientific Corporation
Radiology · 27d
Cleared Feb 10, 2026
MI View&GO
K254016 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 57d
Cleared Feb 10, 2026
GEM Flex Coil 16-L Array, 1.5T Receive Only
K252179 · MOS
Shenzhen RF Tech Co., Ltd.
Radiology · 214d
Cleared Feb 06, 2026
LiveMedica Enterprise PACS
K253927 · LLZ
Live Medica, LLC
Radiology · 60d
Cleared Feb 06, 2026
SIGNA™ Bolt
K253780 · LNH
Ge Medical Systems, LLC
Radiology · 72d
Cleared Feb 06, 2026
Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)
K253221 · IYO
Eieling Technology (Shenzhen) Limited
Radiology · 130d
Cleared Feb 06, 2026
LAIA XR
K251577 · LLZ
Augmented Reality Software S.L.
Radiology · 260d
Cleared Feb 06, 2026
Median LCS (internal name) / eyonis LCS (trade name) (1.0)
K251474 · QDQ
Median Technologies
Radiology · 269d
Cleared Feb 05, 2026
Primevision 3D
K253959 · OAS
Dentsply Sirona
Radiology · 57d