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
2473–2496 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 24, 2021
I-Q View
K203703 · MQB
First Source, Inc.
Radiology · 96d
Cleared Mar 24, 2021
Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System
K203225 · JAK
Canon Medical Systems Corporation
Radiology · 142d
Cleared Mar 23, 2021
Viz ICH
K210209 · QAS
Viz. Ai, Inc.
Radiology · 56d
Cleared Mar 23, 2021
TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound System
K203391 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 125d
Cleared Mar 19, 2021
IMPACT and X-Ranger
K210479 · IZL
Minxray, Inc.
Radiology · 28d
Cleared Mar 19, 2021
VBrain
K203235 · QKB
Vysioneer, Inc.
Radiology · 136d
Cleared Mar 19, 2021
SensorX
K203116 · MUH
Durr Dental SE
Radiology · 154d
Cleared Mar 17, 2021
BBX-PET Scanner
K210450 · KPS
Prescient Imaging, LLC
Radiology · 29d
Cleared Mar 17, 2021
Ziehm Vision RFD
K203428 · JAA
Ziehm Imaging GmbH
Radiology · 117d
Cleared Mar 12, 2021
ProFound AI Software V3.0
K203822 · QDQ
Icad, Inc.
Radiology · 73d
Cleared Mar 12, 2021
TaiChiC
K203250 · IWB
Our United Corporation
Radiology · 128d
Cleared Mar 12, 2021
ADD
K203188 · MQB
H&abyz Co., Ltd.
Radiology · 136d
Cleared Mar 12, 2021
Oncospace
K202284 · MUJ
Oncospace, Inc.
Radiology · 212d
Cleared Mar 10, 2021
Vantage Elan 1.5T, MRT-2020, V6.0
K210164 · LNH
Canon Medical Systems Corporation
Radiology · 48d
Cleared Mar 09, 2021
Quicktome
K203518 · LLZ
Omniscient Neurotechnology Pty Ltd (O8t)
Radiology · 98d
Cleared Mar 09, 2021
Imbio RV/LV Software
K203256 · QIH
Imbio, LLC
Radiology · 125d
Cleared Mar 05, 2021
Cios Select (VA21) Flat Panel
K210309 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Mar 05, 2021
OEC 3D
K203346 · OXO
Ge Oec Medical Systems, Inc.
Radiology · 112d
Cleared Mar 05, 2021
Akesis Galaxy RTi
K203146 · IWB
Akesis, Inc.
Radiology · 135d
Cleared Mar 05, 2021
Vivid E80/ Vivid E90/ Vivid E95
K202658 · IYN
GE Medical Systems Ultrasound and...
Radiology · 172d
Cleared Mar 05, 2021
Optellum Virtual Nodule Clinic, Optellum software, Optellum platform
K202300 · POK
Optellum, Ltd.
Radiology · 204d
Cleared Mar 04, 2021
Cios Select (VA21) Image Intensifier
K210307 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Mar 04, 2021
AlignRT Plus
K203387 · IYE
Vision Rt, Ltd.
Radiology · 106d
Cleared Mar 04, 2021
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
K203323 · LNH
Canon Medical Systems Corporation
Radiology · 112d