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
2305–2328 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Aug 31, 2021
Auto Lung Nodule Detection
K201560 · MYN
Samsung Electronics Co., Ltd.
Radiology · 447d
Cleared Aug 30, 2021
StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2
K212103 · MUH
Fona S.R.L
Radiology · 55d
Cleared Aug 27, 2021
MyoSPECT, MyoSpect ES
K212004 · KPS
Ge Healthcare
Radiology · 60d
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