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
2257–2280 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 01, 2021
Elekta Unity
K212114 · IYE
Elekta Solutions AB
Radiology · 86d
Cleared Sep 30, 2021
Accuray Precision Treatment Planning System
K212794 · IYE
Accuray Incorporated
Radiology · 28d
Cleared Sep 30, 2021
NAEOTOM Alpha, Scan&GO
K211591 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 129d
Cleared Sep 29, 2021
ImmersiveTouch
K210726 · LLZ
Immersivetouch, Inc.
Radiology · 202d
Cleared Sep 28, 2021
SubtlePET
K211964 · KPS
Subtle Medical, Inc.
Radiology · 96d
Cleared Sep 28, 2021
Panther OIS
K211760 · IYE
Prowess, Inc.
Radiology · 112d
Cleared Sep 28, 2021
EzDent Web
K211700 · LLZ
Ewoosoft Co., Ltd.
Radiology · 117d
Cleared Sep 28, 2021
SIDDHARTH-II
K210894 · IYE
Panacea Medical Technologies Pvt. , Ltd.
Radiology · 187d
Cleared Sep 27, 2021
Imaging Plate Scanner, i-Scan
K212080 · MUH
Guilin Woodpecker Medical Instrument...
Radiology · 87d
Cleared Sep 24, 2021
Collaboration Live
K212777 · LLZ
Philips Ultrasound, Inc.
Radiology · 23d
Cleared Sep 24, 2021
Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic...
K212704 · IYN
Philips Medical Systems
Radiology · 29d
Cleared Sep 24, 2021
Virtual C DRF-NEO Digital Imaging System
K212557 · OWB
Portavision Medical, LLC
Radiology · 42d
Cleared Sep 23, 2021
JiveX (Model Number / Release: 5.3)
K212321 · LLZ
Visus Health IT GmbH
Radiology · 59d
Cleared Sep 21, 2021
ProxiDiagnost N90
K212837 · JAA
Philips Medical Systems Dmc GmbH
Radiology · 14d
Cleared Sep 21, 2021
T2
K212303 · OAS
Osstem Implant Co., Ltd.
Radiology · 60d
Cleared Sep 20, 2021
Kubtec Mozart Supra (XPERT 84) Radiography System
K210955 · MWP
Kub Technologies, Inc.
Radiology · 174d
Cleared Sep 17, 2021
Intelligent NR
K212269 · MQB
Canon, Inc.
Radiology · 59d
Cleared Sep 17, 2021
Deep Learning Image Reconstruction
K212067 · JAK
Ge Healthcare Japan Corporation
Radiology · 77d
Cleared Sep 16, 2021
Symbia VA10A Family
K212604 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Sep 16, 2021
6430 MyLabX75, 6430 MyLab XPro75
K212021 · IYN
Esaote, S.P.A.
Radiology · 80d
Cleared Sep 15, 2021
BeamSite
K212606 · IYE
Doseoptics, LLC
Radiology · 29d
Cleared Sep 15, 2021
HealthCCSng
K210085 · JAK
Zebra Medical Vision, Ltd.
Radiology · 245d
Cleared Sep 15, 2021
RXS 1000
K202369 · MUH
Rolence Enterprise, Inc.
Radiology · 392d
Cleared Sep 14, 2021
PHOENIX
K212291 · IZL
Sedecal., Sa.
Radiology · 54d