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
2233–2256 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Aug 27, 2021
LOGIQ E10s, LOGIQ Fortis
K211524 · IYN
Ge Healthcare
Radiology · 102d
Cleared Aug 27, 2021
SOMATOM go.Platform Scanners - SOMATOM go.Now, go.Up, go.All, go.Top, SOMATOM...
K211373 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 115d
Cleared Aug 27, 2021
RBknee
K203696 · LLZ
Radiobotics Aps
Radiology · 252d
Cleared Aug 25, 2021
Diagnostic X-ray System/PLX5200A
K212134 · IZL
Nanjing Perlove Medical Equipment...
Radiology · 48d
Cleared Aug 25, 2021
RFA-1717DIG, RFA-1717DIC
K212051 · MQB
Astel, Inc.
Radiology · 56d
Cleared Aug 24, 2021
SKR 3000
K210619 · MQB
Konica Minolta, Inc.
Radiology · 176d
Cleared Aug 23, 2021
IMRIS iMRI 3T V
K212367 · LNH
Deerfield Imaging, Inc.
Radiology · 24d
Cleared Aug 23, 2021
6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZF
K212105 · MQB
Pzmedical Technology Co., Ltd.
Radiology · 48d
Cleared Aug 23, 2021
EzOrtho
K211793 · LLZ
Ewoosoft Co., Ltd.
Radiology · 74d
Cleared Aug 20, 2021
Ethos Treatment Management, Ethos Treatment Planning
K212294 · IYE
Varian Medical Systems, Inc.
Radiology · 29d
Cleared Aug 20, 2021
Discovery MI Gen2
K211846 · KPS
Ge Medical Systems, LLC
Radiology · 66d
Cleared Aug 20, 2021
Ez3D-i/E3
K211791 · LLZ
Ewoosoft Co., Ltd.
Radiology · 71d
Cleared Aug 20, 2021
Exo Iris
K211527 · IYN
Exo Imaging, Inc.
Radiology · 95d
Cleared Aug 19, 2021
Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W...
K210317 · IYN
Shantou Institute of Ultrasonic...
Radiology · 197d
Cleared Aug 18, 2021
Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging...
K210318 · IYN
Shantou Institute of Ultrasonic...
Radiology · 196d
Cleared Aug 17, 2021
ROSA Hip System
K210998 · LLZ
Orthosoft D/B/A Zimmer Cas
Radiology · 137d
Cleared Aug 17, 2021
Brain Perfusion (BP) application
K201573 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 432d
Cleared Aug 16, 2021
TruSPECT Radiological Image Processing Station
K212230 · LLZ
Spectrum Dynamics Medical, Ltd.
Radiology · 31d
Cleared Aug 13, 2021
EMM Ultrasonic Transducer Cover
K211969 · ITX
Exact Medical Manufacturing
Radiology · 50d
Cleared Aug 13, 2021
ARCO FP-S
K211777 · OWB
A.T.S. Applicazione Tecnologie...
Radiology · 65d
Cleared Aug 13, 2021
NFLK-2501 Portable X-ray Unit
K211383 · IZL
Neuf, Inc.
Radiology · 101d
Cleared Aug 12, 2021
eVolve PACS
K211863 · LLZ
Evolve Pacs, Inc.
Radiology · 57d
Cleared Aug 12, 2021
InferRead CT Stroke.AI
K211179 · QAS
Infervision Medical Technology Co., Ltd.
Radiology · 114d
Cleared Aug 12, 2021
Excelsius3D
K210912 · OWB
Globus Medical, Inc.
Radiology · 136d