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
1033–1056 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Aug 21, 2024
AiMIFY (1.x)
K240290 · LLZ
Subtle Medical, Inc.
Radiology · 202d
Cleared Aug 20, 2024
Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit...
K241496 · LNH
Canon Medical Systems Corporation
Radiology · 84d
Cleared Aug 19, 2024
HealthCCSng
K241440 · JAK
Nano-X AI , Ltd.
Radiology · 90d
Cleared Aug 16, 2024
qCT LN Quant
K240740 · QIH
Qure.Ai Technologies
Radiology · 151d
Cleared Aug 15, 2024
uMI Panvivo
K241596 · KPS
Shanghai United Imaging Healthcare...
Radiology · 73d
Cleared Aug 15, 2024
CoLumbo
K241211 · QIH
Smart Soft Healthcare
Radiology · 107d
Cleared Aug 15, 2024
UltraDrape UGPIV Barrier and Securement (34-15)
K233965 · ITX
Parker Laboratories, Inc.
Radiology · 244d
Cleared Aug 13, 2024
ECHELON Synergy MRI System
K241429 · LNH
Fujifilm Healthcare Corporation
Radiology · 84d
Cleared Aug 13, 2024
Bullsai
K241094 · LLZ
Turing Medical Technologies, Inc.
Radiology · 113d
Cleared Aug 12, 2024
dS FootAnkle Coil 8ch 1.5T
K242096 · MOS
Philips Medical Systems Nederland B.V.
Radiology · 25d
Cleared Aug 12, 2024
OptimMRI (v2)
K242054 · QIH
Rebrain, Sas
Radiology · 28d
Cleared Aug 09, 2024
SonoMax Series Digital Color Doppler Ultrasound System
K233697 · IYN
CHISON Medical Technologies Co., Ltd.
Radiology · 266d
Cleared Aug 08, 2024
Omni Legend
K241665 · KPS
Ge Medical Systems Israel, Functional...
Radiology · 59d
Cleared Aug 08, 2024
SynthVISION 1.0.0
K240724 · LLZ
Synthesis Health Intelligence, Inc.
Radiology · 143d
Cleared Aug 08, 2024
i2Contour
K233822 · QIH
Mrimath, LLC
Radiology · 251d
Cleared Aug 06, 2024
myAblation Guide (VB80A)
K240796 · QTZ
Siemens Healthcare GmbH
Radiology · 137d
Cleared Aug 06, 2024
EOSedge
K233920 · KPR
Eos Imaging
Radiology · 237d
Cleared Aug 05, 2024
AI Platform 2.0 (AIP002)
K240953 · QIH
Exo Imaging
Radiology · 119d
Cleared Aug 05, 2024
Orthopaedic Surgery Planning Software (AIJOINT)
K233761 · LLZ
Longwood Valley Medical , Ltd.
Radiology · 255d
Cleared Aug 02, 2024
Coronis OneLook
K242008 · PGY
Barco N.V.
Radiology · 23d
Cleared Aug 01, 2024
3MP Color LCD Monitor (CL-S301)
K241105 · PGY
Jvckenwood Corporation
Radiology · 101d
Cleared Aug 01, 2024
MammoScreen® (3)
K240301 · QDQ
Therapixel
Radiology · 182d
Cleared Aug 01, 2024
AISAP Cardio V1.0
K234141 · POK
Aisap
Radiology · 216d
Cleared Aug 01, 2024
CardIQ Suite
K233731 · JAK
GE Medical Systems SCS
Radiology · 254d