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
2065–2088 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 30, 2022
VSP Bolus
K214093 · IXI
3D Systems
Radiology · 92d
Cleared Mar 30, 2022
VERIQA
K213370 · IYE
Ptw-Freiburg...
Radiology · 169d
Cleared Mar 30, 2022
Shield System
K212159 · OWB
Radiaction , Ltd.
Radiology · 261d
Cleared Mar 29, 2022
Focus HD 35 Detector
K213646 · MQB
Iray Technology Taicang , Ltd.
Radiology · 145d
Cleared Mar 29, 2022
Focus HD 43 Detector
K213529 · MQB
Iray Technology Taicang , Ltd.
Radiology · 145d
Cleared Mar 28, 2022
Syngo.CT Dual Energy
K212889 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 199d
Cleared Mar 25, 2022
TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10...
K220242 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 56d
Cleared Mar 25, 2022
DTX Studio Clinic 3.0
K213562 · LLZ
Nobel Biocare AB
Radiology · 136d
Cleared Mar 25, 2022
C1210G LCD Monitor, JUSHA-C1210G LCD Monitor, C1210 LCD Monitor, JUSHA-C1210...
K212231 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 252d
Cleared Mar 23, 2022
DRX-Rise Mobile X-ray System
K213568 · IZL
Carestream Health
Radiology · 134d
Cleared Mar 22, 2022
LOGIQ P10, LOGIQ P9, LOGIQ P8
K214039 · IYN
GE Medical Systems Ultrasound and...
Radiology · 89d
Cleared Mar 22, 2022
Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5
K212960 · IYN
Canon Medical Systems Corporation
Radiology · 187d
Cleared Mar 21, 2022
BriefCase
K213721 · QAS
Aidoc Medical , Ltd.
Radiology · 117d
Cleared Mar 18, 2022
SURGIVISIO Device
K220627 · OWB
Ecential Robotics
Radiology · 14d
Cleared Mar 16, 2022
Customize
K213779 · QIH
3D-Side S.A.
Radiology · 103d
Cleared Mar 16, 2022
EchoSK and EchoSGyn modules for EchoS Family devices
K212851 · IYO
Echolight S.P.A
Radiology · 190d
Cleared Mar 14, 2022
BriefCase
K214043 · QFM
Aidoc Medical , Ltd.
Radiology · 81d
Cleared Mar 14, 2022
Arterys MICA
K203744 · QIH
Arterys, Inc.
Radiology · 447d
Cleared Mar 11, 2022
MAGNETOM Vida, MAGNETOM Sola
K220425 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 25d
Cleared Mar 11, 2022
Dental sensors NanoPix1, NanoPix2
K220422 · MUH
Iray Technology Taicang , Ltd.
Radiology · 25d
Cleared Mar 11, 2022
CardIQ Suite
K213725 · JAK
GE Medical Systems SCS
Radiology · 105d
Cleared Mar 11, 2022
32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR...
K213687 · MOS
Neocoil, LLC
Radiology · 108d
Cleared Mar 11, 2022
RI.HIP MODELER
K212040 · LLZ
Blue Belt Technologies, Inc.
Radiology · 254d
Cleared Mar 10, 2022
ClearRead Xray Pneumothorax
K213566 · QFM
Riverain Technologies, Inc.
Radiology · 121d