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
2425–2448 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 02, 2021
Mars1717X Wireless Digital Flat Panel Detector
K210314 · MQB
Iray Technology Taicang , Ltd.
Radiology · 27d
Cleared Mar 02, 2021
MRI PPG Patient Cable
K203653 · LNH
Ivy Biomedical Systems, Inc.
Radiology · 77d
Cleared Mar 02, 2021
MaxFOV 2
K203617 · JAK
Ge Medical Systems, LLC
Radiology · 81d
Cleared Mar 02, 2021
SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G...
K201965 · IYN
CHISON Medical Technologies Co., Ltd.
Radiology · 230d
Cleared Feb 26, 2021
Cuptimize
K203651 · LLZ
Cuptimize, Inc.
Radiology · 74d
Cleared Feb 26, 2021
SubtleMR
K203182 · LLZ
Subtle Medical, Inc.
Radiology · 122d
Cleared Feb 26, 2021
Spectral CT
K203020 · JAK
Philips Medical Systems Nederland B.V.
Radiology · 147d
Cleared Feb 26, 2021
SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound System
K201968 · IYN
CHISON Medical Technologies Co., Ltd.
Radiology · 226d
Cleared Feb 26, 2021
SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System
K201967 · IYN
CHISON Medical Technologies Co., Ltd.
Radiology · 226d
Cleared Feb 26, 2021
Bladder Scanner (Model: M3, M3-HD, M4, M4-HD)
K201316 · IYO
Suzhou Peaksonic Medical Technology...
Radiology · 284d
Cleared Feb 25, 2021
NinesMeasure
K202990 · LLZ
Nines, Inc.
Radiology · 148d
Cleared Feb 25, 2021
EchoS Family
K202514 · MUA
Echolight S.P.A
Radiology · 178d
Cleared Feb 25, 2021
SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound System
K201971 · IYN
CHISON Medical Technologies Co., Ltd.
Radiology · 225d
Cleared Feb 25, 2021
SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound System
K201969 · IYN
CHISON Medical Technologies Co., Ltd.
Radiology · 225d
Cleared Feb 23, 2021
PreXion3D Explorer PRO
K203784 · OAS
Prexion Corporation
Radiology · 57d
Cleared Feb 23, 2021
Lumify Diagnostic Ultrasound System
K203406 · IYN
Philips Ultrasound, Inc.
Radiology · 96d
Cleared Feb 23, 2021
Monaco Rtp System
K202789 · MUJ
Elekta Solutions AB
Radiology · 154d
Cleared Feb 23, 2021
ClarifEye R1.0, ClarifEye Needle
K201743 · OWB
Philips Medical Systems Nederlands B.V.
Radiology · 243d
Cleared Feb 23, 2021
Veolity
K201501 · OEB
Mevis Medical Solutions AG
Radiology · 263d
Cleared Feb 19, 2021
X-ray Flat Panel Detectors/CareView 3600RF
K202995 · MQB
Careray Digital Medical System Co., Ltd.
Radiology · 141d
Cleared Feb 19, 2021
TruPlan
K202212 · LLZ
Circle Cardiovascular Imaging, Inc.
Radiology · 197d
Cleared Feb 19, 2021
Disposable Intraoperative Probe (DIOP8)
K201425 · ITX
Huntleigh Healthcare Limited
Radiology · 266d
Cleared Feb 19, 2021
MyPAO Planning Report
K200589 · LLZ
Medacta International S.A.
Radiology · 350d
Cleared Feb 18, 2021
Green X 18(Model : PHT-75CHS)
K210329 · OAS
VATECH Co., Ltd.
Radiology · 14d