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
2281–2304 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Sep 09, 2021
HERA W9, HERA W10 Diagnostic Ultrasound System
K211824 · IYN
Samsung Medison Co., Ltd.
Radiology · 87d
Cleared Sep 08, 2021
V8 Diagnostic Ultrasound System
K211945 · IYN
Samsung Medison Co., Ltd.
Radiology · 77d
Cleared Sep 08, 2021
RayStation 11.0
K211867 · MUJ
RaySearch Laboratories AB (PUBL)
Radiology · 84d
Cleared Sep 08, 2021
EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic...
K211597 · IYN
Philips Medical Systems
Radiology · 107d
Cleared Sep 08, 2021
AmCAD-UT
K203555 · QIH
Amcad Biomed Corporation
Radiology · 275d
Cleared Sep 03, 2021
ADAS 3D
K212421 · LLZ
Adas3D Medical S.L.
Radiology · 30d
Cleared Sep 02, 2021
Lung Image Analysis
K212494 · JAK
Pulmonx Corporation
Radiology · 24d
Cleared Sep 02, 2021
AI Segmentation
K211881 · MUJ
Varian Medical Systems, Inc.
Radiology · 73d
Cleared Sep 02, 2021
RayPilot System
K203722 · IYE
Micropos Medical AB
Radiology · 255d
Cleared Aug 31, 2021
EndoNaut
K212383 · OWB
Therenva Sas
Radiology · 29d
Cleared Aug 31, 2021
DR 800 with DSA, DR 800
K212145 · JAA
Agfa N.V.
Radiology · 53d
Cleared Aug 31, 2021
Kubec Xpert 80 Radiography System
K210957 · MWP
Kub Technologies, Inc.
Radiology · 154d
Cleared Aug 31, 2021
Kubtec Mozart (XPERT42)
K210956 · MWP
Kub Technologies, Inc.
Radiology · 154d