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
1753–1776 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 16, 2022
Overjet Calculus Assist
K220928 · MYN
Overjet, Inc.
Radiology · 260d
Cleared Dec 15, 2022
Small Field Applicator
K220883 · LHN
Hitachi, Ltd. Radiation Oncology...
Radiology · 265d
Cleared Dec 09, 2022
3D-SHAPER
K220822 · KGI
3D-Shaper Medical S.L
Radiology · 263d
Cleared Dec 08, 2022
InkSpace Imaging Body Array
K223487 · MOS
Inkspace Imaging, Inc.
Radiology · 17d
Cleared Dec 08, 2022
8ch Wrist Coil
K223239 · MOS
Shenzhen RF Tech Co., Ltd.
Radiology · 49d
Cleared Dec 07, 2022
Cios Select (VA21) Flat Panel
K223410 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared Dec 07, 2022
Ultrasound System 2300
K222441 · IYN
Bk Medical Aps
Radiology · 117d
Cleared Dec 06, 2022
Cios Select (VA21) Image Intensifier
K223409 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 27d
Cleared Dec 06, 2022
Swoop Portable MR Imaging System
K223247 · LNH
Hyperfine, Inc.
Radiology · 46d
Cleared Dec 06, 2022
MedDream
K222320 · LLZ
Softneta Uab
Radiology · 126d
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