FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,620 results
961–984 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Jul 30, 2024
WERAY
K241963 · EHD
Picopack Co., Ltd.
Radiology · 27d
Cleared Jul 26, 2024
Symbia SPECT and SPECT/CT Systems
K241898 · KPS
Siemens Healthineers
Radiology · 28d
Cleared Jul 26, 2024
EXSYS DEXi (EXSYS DEXi-D401S-FRM)
K233530 · KPR
DRTECH Corporation
Radiology · 267d