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
2161–2184 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 23, 2021
D²RS and D²RS 9090
K213479 · OWB
Stephanix
Radiology · 55d
Cleared Dec 22, 2021
Solas OR
K213691 · MWP
Cirdan Imaging, Ltd.
Radiology · 29d
Cleared Dec 22, 2021
iSR’obot Mona Lisa 2.0
K213411 · IYO
Biobot Surgical Pte., Ltd.
Radiology · 64d
Cleared Dec 22, 2021
Claritas iPET
K213140 · LLZ
Claritas Healthtech Pte, Ltd.
Radiology · 86d
Cleared Dec 22, 2021
Ultrast Gel
K211691 · MUI
Ultrast, Inc.
Radiology · 203d
Cleared Dec 22, 2021
BoneMRI
K202404 · QIH
Mriguidance B.V.
Radiology · 488d
Cleared Dec 21, 2021
qXR-BT
K212690 · QIH
Qure.Ai Technologies
Radiology · 118d
Cleared Dec 21, 2021
BU-CAD
K210670 · QDQ
Taihao Medical, Inc.
Radiology · 291d
Cleared Dec 20, 2021
EchoGo Core (2.0)
K213275 · QIH
Ultromics Limited
Radiology · 81d
Cleared Dec 17, 2021
Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex...
K213715 · JAK
Ge Medical Systems, LLC
Radiology · 23d
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