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
1321–1344 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 08, 2023
DTX Studio Clinic (4.0)
K231898 · LLZ
Nobel Biocare AB
Radiology · 163d
Cleared Dec 08, 2023
Bonelogic
K223757 · QIH
Disior, Ltd.
Radiology · 358d
Cleared Dec 07, 2023
Myocardial Strain Software Application
K232661 · LLZ
Circle Cardiovascular Imaging
Radiology · 98d
Cleared Dec 07, 2023
LOGIQ Totus
K232381 · IYN
GE Medical Systems Ultrasound and...
Radiology · 121d
Cleared Dec 06, 2023
Sonosite LX Ultrasound System
K233597 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 28d
Cleared Dec 06, 2023
Aquilion Serve SP (TSX-307B/1) V1.3
K233334 · JAK
Canon Medical Systems Corporation
Radiology · 68d
Cleared Dec 06, 2023
SOMATOM Pro.Pulse
K232206 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 134d
Cleared Dec 05, 2023
Ceevra Reveal 3+
K233568 · QIH
Ceevra, Inc.
Radiology · 29d
Cleared Dec 05, 2023
Adravision Perio
K232440 · QIH
Adra Corporation
Radiology · 113d
Cleared Dec 01, 2023
Syngo Carbon Clinicals
K232856 · QIH
Siemens Healthcare GmbH
Radiology · 77d
Cleared Nov 30, 2023
EPIQ Series Diagnostic Ultrasound System
K233545 · IYN
Philips Ultrasound, LLC
Radiology · 27d
Cleared Nov 30, 2023
syngo.CT Dual Energy
K232155 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 133d
Cleared Nov 29, 2023
MULTIX Impact E
K233532 · KPR
Siemens Medical Solutions
Radiology · 27d
Cleared Nov 29, 2023
uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with...
K231482 · JAK
Shanghai United Imaging Healthcare...
Radiology · 190d
Cleared Nov 29, 2023
6440 MyLabX90
K230179 · IYN
Esaote, S.P.A.
Radiology · 310d
Cleared Nov 28, 2023
N1
K232012 · EHD
Osstem Implant Co., Ltd.
Radiology · 145d
Cleared Nov 28, 2023
syngo.via MI Workflows
K232000 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 146d
Cleared Nov 28, 2023
BriefCase-Quantification
K231631 · JAK
Aidoc Medical , Ltd.
Radiology · 176d
Cleared Nov 21, 2023
DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size...
K233053 · MUH
Dental Imaging Technologies Corporation
Radiology · 57d
Cleared Nov 21, 2023
Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System
K232988 · IYN
Canon Medical Systems Corporation
Radiology · 60d
Cleared Nov 21, 2023
Brainomix 360 Triage Stroke
K232496 · QAS
Brainomix Limited
Radiology · 96d
Cleared Nov 20, 2023
ARIETTA x10
K231941 · IYN
Fujifilm Healthcare Americas Corporation
Radiology · 143d
Cleared Nov 20, 2023
Ziehm Vision RFD
K231692 · OWB
Ziehm Imaging GmbH
Radiology · 164d
Cleared Nov 20, 2023
TraumaCad Neo
K231498 · LLZ
Brainlab , Ltd.
Radiology · 180d