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 × Cleared only ×
15,676 results
2209–2232 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 10, 2021
Lunit INSIGHT CXR Triage
K211733 · QFM
Lunit, Inc.
Radiology · 159d
Cleared Nov 10, 2021
inVisionOS
K210344 · LLZ
Precisionos Technology, Inc.
Radiology · 278d
Cleared Nov 08, 2021
FDR Cross (DR-XD 3000)
K212956 · OWB
Fujifilm Corporation
Radiology · 53d
Cleared Nov 08, 2021
Hura CTP v1.0
K212550 · LLZ
Hura Imaging, Inc.
Radiology · 87d
Cleared Nov 08, 2021
GIQuant
K211356 · LLZ
Motilent, Ltd.
Radiology · 189d
Cleared Nov 05, 2021
MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic...
K212900 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 53d
Cleared Nov 05, 2021
Visible Patient Suite
K212896 · LLZ
Visible Patient, Sas
Radiology · 56d
Cleared Nov 05, 2021
VFSS Pro Mobile Digital Imaging System
K212523 · OWB
Imagexray, LLC
Radiology · 86d
Cleared Nov 05, 2021
Acuson SC2000 Diagnostic Ultrasound System
K211726 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 154d
Cleared Nov 03, 2021
MOVIX DReamy
K212515 · IZL
Stephanix
Radiology · 85d
Cleared Nov 03, 2021
LELTEK Ultrasound Imaging System (Model: LU700 Series)
K210432 · IYN
Leltek, Inc.
Radiology · 264d
Cleared Nov 03, 2021
SyMRI
K203372 · LNH
Syntheticmr AB
Radiology · 352d
Cleared Nov 02, 2021
VisionX 3.0
K213326 · LLZ
Durr Dental SE
Radiology · 28d
Cleared Nov 02, 2021
TaiChiB
K210921 · IYE
Our United Corporation
Radiology · 218d
Cleared Oct 29, 2021
ds Head 32ch 3.0T
K213351 · MOS
Invivo Corporation (Business Trade...
Radiology · 21d
Cleared Oct 29, 2021
ATEC Alignment App
K211987 · LLZ
Alphatec Spine, Inc.
Radiology · 123d
Cleared Oct 29, 2021
Critical Care Suite with Endotracheal Tube Positing AI algorithm
K211161 · QIH
Ge Medical Systems, LLC
Radiology · 193d
Cleared Oct 29, 2021
nView s1 with nav option
K211064 · OWB
Nview Medical
Radiology · 203d
Cleared Oct 26, 2021
CLISIS SYSTEMS, Discovery RF180
K213081 · IZF
General Medical Merate S.P.A
Radiology · 33d
Cleared Oct 25, 2021
Advanced Algorithms for Treatment Management Applications (AATMA)
K212218 · QKB
Elekta Solutions AB
Radiology · 101d
Cleared Oct 22, 2021
FlightPlan for Liver
K210807 · LLZ
GE Medical Systems SCS
Radiology · 219d
Cleared Oct 21, 2021
Orthoscan Tau Mini C-Arm
K213113 · OXO
Orthoscan, Inc.
Radiology · 24d
Cleared Oct 20, 2021
iRAD
K212470 · LLZ
Claritas Healthtech Pte, Ltd.
Radiology · 75d
Cleared Oct 20, 2021
Contour ProtegeAI
K210632 · QKB
Mim Software, Inc.
Radiology · 231d