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
2257–2280 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Sep 13, 2021
KONICAMINOLTA DI-X1
K212685 · LLZ
Konica Minolta, Inc.
Radiology · 20d
Cleared Sep 13, 2021
IRIS-XP
K212412 · LHQ
Medicore Co., Ltd.
Radiology · 41d
Cleared Sep 13, 2021
CIV-Clear cover
K211270 · ITX
CIVCO Medical Instruments Co., Inc.
Radiology · 139d
Cleared Sep 10, 2021
Aquilion Exceed LB
K211828 · JAK
Canon Medical Systems Corporation
Radiology · 88d
Cleared Sep 10, 2021
LOGIQ E10
K211488 · IYN
Ge Healthcare
Radiology · 120d
Cleared Sep 10, 2021
EFAI PACS Picture Archiving and Communication System
K211257 · LLZ
Ever Fortune.Ai, Co., Ltd.
Radiology · 137d
Cleared Sep 10, 2021
Versana Premier
K210438 · IYN
GE Medical Systems Ultrasound and...
Radiology · 210d
Cleared Sep 10, 2021
AccuFFRangio
K210093 · QHA
ArteryFlow Technology Co., Ltd.
Radiology · 239d
Cleared Sep 10, 2021
ClariSIGMAM
K203785 · QIH
Claripi, Inc.
Radiology · 256d
Cleared Sep 10, 2021
Kinepict Medical Imaging Tool 4.0
K202056 · LLZ
Kinepict Health, Ltd.
Radiology · 413d
Cleared Sep 09, 2021
DIGITAL RADIOGRAPHY CXDI-Pro, D1
K212553 · MQB
Canon, Inc.
Radiology · 27d