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
1393–1416 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 10, 2023
WeSensor
K230916 · MUH
Picopack, Inc.
Radiology · 190d
Cleared Oct 10, 2023
Micromate™ Navi+
K230130 · JAK
Isys Medizintechnik GmbH
Radiology · 266d
Cleared Oct 06, 2023
Swoop® Portable MR Imaging System®
K232760 · LNH
Hyperfine, Inc.
Radiology · 28d
Cleared Oct 06, 2023
ProBeam 360° Proton Therapy System v2.0 (Multiroom)
K231863 · LHN
Varian Medical Systems, Inc.
Radiology · 105d
Cleared Oct 06, 2023
Denti.AI Detect
K230144 · MYN
Denti.Ai Technology, Inc.
Radiology · 261d
Cleared Oct 05, 2023
Clarius Ultrasound Scanner
K232704 · IYN
Clarius Mobile Health Corp.
Radiology · 30d
Cleared Oct 05, 2023
cmAngio® V1.0
K232367 · QIH
Curemetrix, Inc.
Radiology · 58d
Cleared Oct 05, 2023
DeepTek CXR Analyzer v1.0
K231001 · MYN
Deeptek Medical Imaging Pvt, Ltd.
Radiology · 181d
Cleared Oct 04, 2023
VUNO Med-DeepBrain
K231398 · QIH
Vuno, Inc.
Radiology · 142d
Cleared Oct 04, 2023
EFAI NeuroSuite CT ICH Assessment System
K231025 · QAS
Ever Fortune.Ai, Co., Ltd.
Radiology · 176d
Cleared Oct 03, 2023
dS Breast Coil 7ch 1.5T
K232762 · MOS
Invivo Corporation (Business Trade...
Radiology · 25d
Cleared Oct 03, 2023
uMI Panorama
K232712 · KPS
Shanghai United Imaging Healthcare...
Radiology · 28d
Cleared Oct 03, 2023
V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6...
K231772 · IYN
Samsung Medison Co., Ltd.
Radiology · 109d
Cleared Oct 03, 2023
Lung-CAD
K230085 · MYN
Imagen Technologies, Inc.
Radiology · 265d
Cleared Sep 29, 2023
Terran NM-101
K230187 · LNH
Terran Biosciences, Inc.
Radiology · 249d
Cleared Sep 29, 2023
HipCheck
K230045 · QIH
Stryker Corp.
Radiology · 266d
Cleared Sep 28, 2023
Brainomix 360 Triage LVO
K231837 · QAS
Brainomix Limited
Radiology · 98d
Cleared Sep 27, 2023
EZSensor XHD
K232255 · MUH
Qpix Solutions, Inc.
Radiology · 61d
Cleared Sep 26, 2023
ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic...
K232617 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Sep 26, 2023
ES Series V2
K232336 · IYN
E-Scopics
Radiology · 53d
Cleared Sep 26, 2023
OFIX MIS App
K230252 · LLZ
Orthofix US, LLC
Radiology · 239d
Cleared Sep 25, 2023
EFAI RTSUITE CT HCAP-Segmentation System
K231928 · QKB
Ever Fortune.Ai, Co., Ltd.
Radiology · 87d
Cleared Sep 22, 2023
Annalise Enterprise CTB Triage Trauma
K231767 · QAS
Annalise-Ai Pty , Ltd.
Radiology · 98d
Cleared Sep 22, 2023
Annalise Enterprise CTB Triage Trauma
K231384 · QAS
Annalise-Ai Pty , Ltd.
Radiology · 133d