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
2089–2112 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 02, 2021
Clivia series Diagnostic Ultrasound System
K211886 · IYN
Shenzhen Wisonic Medical Technology...
Radiology · 164d
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