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 ×
15,589 results
865–888 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 11, 2024
syngo Application Software
K241569 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 133d
Cleared Oct 10, 2024
uDR 380i Pro
K242515 · IZL
Shanghai United Imaging Healthcare...
Radiology · 48d
Cleared Oct 10, 2024
EchoMeasure
K241430 · QIH
Icardio.Ai
Radiology · 142d
Cleared Oct 10, 2024
AutoChamber
K240786 · QIH
HeartLung Corporation
Radiology · 202d
Cleared Oct 09, 2024
Limbus Contour
K241837 · QKB
Limbus Ai, Inc.
Radiology · 106d
Cleared Oct 07, 2024
SpineUs™ System
K241029 · IYO
Verdure Imaging
Radiology · 175d
Cleared Oct 07, 2024
EPIQ Series Diagnostic Ultrasound System
K240980 · IYN
Philips Ultrasound, LLC
Radiology · 180d
Cleared Oct 04, 2024
Lunit INSIGHT DBT v1.1
K242652 · QDQ
Lunit, Inc.
Radiology · 30d
Cleared Oct 04, 2024
EchoSolv AS
K241245 · POK
Echo IQ, Ltd.
Radiology · 154d
Cleared Oct 04, 2024
LVivo Software Application
K240553 · QIH
Dia Imaging Analysis, Ltd.
Radiology · 219d
Cleared Oct 02, 2024
Versana Premier
K242005 · IYN
GE Medical Systems Ultrasound and...
Radiology · 85d
Cleared Oct 02, 2024
VitruvianScan (v1.0)
K241925 · LNH
Perspectum, Ltd.
Radiology · 93d
Cleared Oct 02, 2024
MammoScreen BD
K241561 · QIH
Therapixel
Radiology · 124d
Cleared Oct 01, 2024
Definium Pace Select ET
K242678 · KPR
Ge Hualun Medical Systems Co. , Ltd.
Radiology · 25d
Cleared Oct 01, 2024
GM85
K242651 · IZL
Samsung Electronics Co., Ltd.
Radiology · 27d
Cleared Oct 01, 2024
MuscleView
K241331 · LNH
Springbok, Inc.
Radiology · 144d
Cleared Oct 01, 2024
LungVision
K240943 · QIH
Bodyvision Medical , Ltd.
Radiology · 179d
Cleared Sep 27, 2024
JBS-LVO
K241480 · QAS
JLK, Inc.
Radiology · 126d
Cleared Sep 27, 2024
CAC (gated) Algorithm
K240369 · JAK
BunkerHill Health
Radiology · 233d
Cleared Sep 24, 2024
uAI Easy Triage ICH
K242292 · QAS
Shanghai United Imaging Intelligence...
Radiology · 53d
Cleared Sep 23, 2024
EConsole2
K240243 · LLZ
DRTECH Corporation
Radiology · 237d
Cleared Sep 20, 2024
SuperSonic HepaVu
K242223 · IYN
Supersonic Imagine
Radiology · 53d
Cleared Sep 20, 2024
PIUR tUS Infinity
K240036 · QIH
Piur Imaging GmbH
Radiology · 259d
Cleared Sep 20, 2024
ERI Portable X-ray System (CVX-air)
K234108 · IZL
Energy Resources International Co., Ltd.
Radiology · 268d