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
2161–2184 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 17, 2021
InkSpace Imaging Pediatric Body Array
K213397 · MOS
Inkspace Imaging, Inc.
Radiology · 60d
Cleared Dec 16, 2021
VBrain
K213628 · QKB
Vysioneer, Inc.
Radiology · 29d
Cleared Dec 16, 2021
6MP Color LCD Monitor CL-S600
K212985 · PGY
Jvckenwood Corporation
Radiology · 90d
Cleared Dec 16, 2021
Koios DS
K212616 · POK
Koios Medical, Inc.
Radiology · 120d
Cleared Dec 16, 2021
Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements...
K212420 · LLZ
Brainlab AG
Radiology · 134d
Cleared Dec 15, 2021
RT-Mind-AI
K213155 · QKB
Medmind Technology Co., Ltd.
Radiology · 78d
Cleared Dec 15, 2021
HealthPPT
K211803 · QFM
Zebra Medical Vision, Ltd.
Radiology · 187d
Cleared Dec 15, 2021
Will3D
K211114 · LLZ
Hdx Will Corp.
Radiology · 245d
Cleared CT Dec 15, 2021
BIT-Motion
K211039 · LLZ
Dde Mri Solutions, Ltd.
Radiology · 252d
Cleared Dec 15, 2021
Helianthus
K202822 · MUE
Metaltronica Spa
Radiology · 447d
Cleared Dec 14, 2021
MRIdian Linac System
K212958 · IYE
Viewray, Incorporated
Radiology · 89d
Cleared Dec 13, 2021
MULTIX Impact, MULTIX Impact C
K213700 · KPR
Siemens Medical Solutions USA, Inc.
Radiology · 20d
Cleared Dec 13, 2021
Nyquist.IQ
K212890 · JAA
Omega Medical Imaging, LLC
Radiology · 94d
Cleared Dec 13, 2021
Philips Radiology Smart Assistant
K212186 · KPR
Philips Medical Systems Dmc GmbH
Radiology · 153d
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
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