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
2401–2424 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Mar 03, 2021
Mars 1417X Wireless Digital Flat Panel Detector
K210316 · MQB
Iray Technology Taicang , Ltd.
Radiology · 28d
Cleared Mar 03, 2021
Biograph Vision Quadra PET/CT System
K210262 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Mar 03, 2021
Promaxo MRI System
K202518 · LNH
Promaxo, Inc.
Radiology · 183d