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
2209–2232 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 17, 2021
Soteria.AI
K212336 · OWB
Omega Medical Imaging, LLC
Radiology · 113d
Cleared Nov 17, 2021
Lunit INSIGHT MMG
K211678 · QDQ
Lunit, Inc.
Radiology · 169d
Cleared Nov 16, 2021
TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound...
K212265 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 119d
Cleared Nov 15, 2021
ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)
K213497 · MQB
H&abyz Co., Ltd.
Radiology · 14d
Cleared Nov 15, 2021
Clarius Ultrasound Scanner
K213436 · IYN
Clarius Mobile Health Corp.
Radiology · 24d
Cleared Nov 15, 2021
Axialis Ophthalmic Ultrasound System
K213254 · IYO
Quantel Medical
Radiology · 46d
Cleared Nov 12, 2021
MiPACS HTML5 Web Viewer
K212984 · LLZ
Lead Technologies, Inc.
Radiology · 56d
Cleared Nov 12, 2021
MAMMOVISTA B.smart
K212621 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 86d
Cleared Nov 12, 2021
Intellijoint VIEW
K211876 · LLZ
Intellijoint Surgical, Inc.
Radiology · 148d
Cleared Nov 10, 2021
RTapp
K212887 · LLZ
Segana, Inc.
Radiology · 61d
Cleared Nov 10, 2021
AlignRT Plus
K212583 · IYE
Vision Rt, Ltd.
Radiology · 86d
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