FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,589 results
1657–1680 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 06, 2022
R2 Studio Q/RCT820
K222219 · OAS
Megagen Implant Co., Ltd.
Radiology · 134d
Cleared Dec 05, 2022
BriefCase
K222692 · QFM
Aidoc Medical , Ltd.
Radiology · 90d
Cleared Dec 05, 2022
ClearRead CT
K221612 · OEB
Riverain Technologies, Inc.
Radiology · 185d
Cleared Dec 02, 2022
CardioGraphe
K213465 · JAK
Arineta , Ltd.
Radiology · 400d
Cleared Dec 01, 2022
ProBeam 360° Proton Therapy System
K221791 · LHN
Varian Medical Systems, Inc.
Radiology · 163d
Cleared Dec 01, 2022
Bolt Navigation System
K213768 · OWB
Circinus Medical Technology, LLC
Radiology · 365d
Cleared Nov 28, 2022
TorchTM Software
K220630 · LLZ
Voximetry, Incorporated
Radiology · 269d
Cleared Nov 27, 2022
Wireless/Wired X-Ray Flat Panel Detectors
K223009 · MQB
Allengers Medical Systems Limited
Radiology · 59d
Cleared Nov 25, 2022
VSI HoloMedicine
K213215 · LLZ
Apoqlar GmbH
Radiology · 422d
Cleared Nov 23, 2022
Ai Ray Dental X-Ray Device
K222569 · EHD
Guilin Woodpecker Medical Instrument...
Radiology · 91d
Cleared Nov 22, 2022
Vision 2, EVARVision, TrackVision 2, HeartVision 2
K223152 · LLZ
GE Medical Systems SCS
Radiology · 47d
Cleared Nov 22, 2022
DynamicIQ
K222895 · KPS
GE Medical Systems SCS
Radiology · 60d
Cleared Nov 22, 2022
Denti.AI Auto-Chart
K222054 · LLZ
Denti.Ai Technology, Inc.
Radiology · 133d
Cleared Nov 22, 2022
VitroPRO
K222052 · ITX
CIVCO Medical Instruments Co., Inc.
Radiology · 133d
Cleared Nov 22, 2022
CINA
K221716 · QAS
Avicenna.Ai
Radiology · 162d
Cleared Nov 22, 2022
Avenda Health AI Prostate Cancer Planning Software
K221624 · POK
Avenda Health, Inc.
Radiology · 169d
Cleared Nov 22, 2022
Minimally Invasive Prostate Surgery Navigation System
K221499 · LLZ
Augment Intelligent Medical System...
Radiology · 183d
Cleared Nov 22, 2022
AccuCTP
K220663 · LLZ
ArteryFlow Technology Co., Ltd.
Radiology · 260d
Cleared Nov 21, 2022
SIS System (Version 5.6.0)
K223032 · QIH
Surgical Information Sciences, Inc.
Radiology · 53d
Cleared Nov 21, 2022
SM-V
K222951 · IZL
Sedecal., Sa.
Radiology · 55d
Cleared Nov 18, 2022
EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG
K223124 · MQB
DRTECH Corporation
Radiology · 46d
Cleared Nov 18, 2022
BriefCase
K221330 · QAS
Aidoc Medical , Ltd.
Radiology · 196d
Cleared Nov 17, 2022
SKR 3000
K223267 · MQB
Konica Minolta, Inc.
Radiology · 24d
Cleared Nov 17, 2022
OmegaAI Image Viewer
K222476 · LLZ
Ramsoft, Inc.
Radiology · 93d