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
2185–2208 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 01, 2021
Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit...
K213305 · LNH
Canon Medical Systems Corporation
Radiology · 58d
Cleared Dec 01, 2021
dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T
K212864 · MOS
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 84d
Cleared Nov 29, 2021
RCT700
K213226 · OAS
Ray Co., Ltd.
Radiology · 61d
Cleared Nov 26, 2021
MammoScreen 2.0
K211541 · QDQ
Therapixel
Radiology · 191d
Cleared Nov 24, 2021
ControlRad Select Model Z
K213455 · OWB
Controlrad, Inc.
Radiology · 29d
Cleared Nov 24, 2021
AMRA Profiler
K211983 · LNH
Amra Medical AB
Radiology · 152d
Cleared Nov 23, 2021
Myomics Q
K211432 · LLZ
Phantomics, Inc.
Radiology · 200d
Cleared Nov 22, 2021
Philips Incisive CT on Trailer
K211168 · JAK
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 217d
Cleared Nov 19, 2021
MR 5300
K212673 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 87d
Cleared Nov 19, 2021
OnQ Neuro
K210831 · QIH
Cortechs Labs, Inc.
Radiology · 245d
Cleared Nov 18, 2021
VALORY
K213469 · MQB
Agfa N.V.
Radiology · 21d
Cleared Nov 18, 2021
MD-320W Ultrasound Biomicroscope
K213070 · IYO
MEDA Co., Ltd.
Radiology · 56d
Cleared Nov 17, 2021
Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
K212456 · LNH
Hyperfine, Inc.
Radiology · 104d
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