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
2137–2160 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jan 14, 2022
Precise Image
K210760 · JAK
Philips Medical Systems Nederland B.V.
Radiology · 305d
Cleared Jan 13, 2022
Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert
K213642 · IYN
Ge Healthcare
Radiology · 56d
Cleared Jan 12, 2022
Straight Arm DDR
K214012 · KPR
Konica Minolta Healthcare Americas, Inc.
Radiology · 21d
Cleared Jan 12, 2022
UNiD Spine Analyzer
K212005 · LLZ
Medicrea International, Inc.
Radiology · 198d
Cleared Jan 11, 2022
Esteya
K213942 · JAD
Nucletron B.V.
Radiology · 25d
Cleared Jan 11, 2022
ES1 System
K213102 · IYN
E-Scopics
Radiology · 109d
Cleared Jan 07, 2022
AIBOLIT 3D+
K211443 · LLZ
Aibolit Technologies, LLC
Radiology · 242d
Cleared Jan 06, 2022
TOMTEC-ARENA
K213544 · QIH
Tomtec Imaging Systems GmbH
Radiology · 59d
Cleared Jan 06, 2022
Gold Anchor
K213053 · IYE
Naslund Medical AB
Radiology · 106d
Cleared Jan 03, 2022
VUZE System
K210830 · LLZ
Vuze Medical , Ltd.
Radiology · 290d
Cleared Dec 30, 2021
eco-x Series (eco-x, eco-x-s)
K211159 · OAS
Hdx Will Corp.
Radiology · 255d
Cleared Dec 29, 2021
LiverSmart
K213776 · PCS
Resonance Health Analysis Services...
Radiology · 27d
Cleared Dec 27, 2021
Sonosite PX Ultrasound System
K213763 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 26d
Cleared Dec 23, 2021
dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for...
K213766 · MOS
Invivo Corporation
Radiology · 22d
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