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
2185–2208 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 10, 2021
JAZZ Solo sensor
K213637 · MUH
Jazz Imaging, LLC Dba Jazz Imaging
Radiology · 22d
Cleared Dec 10, 2021
X-Clever
K212137 · LLZ
Lg Electronics.Inc
Radiology · 155d
Cleared Dec 10, 2021
EXA
K203743 · LLZ
Konica Minolta Healthcare Americas, Inc.
Radiology · 353d
Not Cleared Dec 10, 2021
Comfort Marker 2.0.
DEN200041 · QRN
Medical Precision BV
Radiology · 536d
Cleared Dec 09, 2021
LVivo Seamless
K212466 · QIH
Dia Imaging Analysis, Ltd.
Radiology · 125d
Cleared Dec 06, 2021
Al-Rad Companion (Pulmonary)
K213096 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 73d
Cleared Dec 03, 2021
Cydar EV (Series B) and Cydar EV Maps
K212442 · OWB
Cydar , Ltd.
Radiology · 121d
Cleared Dec 03, 2021
21HQ513D
K212295 · PGY
Lg Electronics.Inc
Radiology · 134d
Cleared Dec 03, 2021
PVmed Contouring Software
K210916 · LLZ
Perception Vision Medical...
Radiology · 249d
Cleared Dec 03, 2021
ImplaStation
K210241 · LLZ
Prodigident, Inc.
Radiology · 308d
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