FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,620 results
2209–2232 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Aug 31, 2021
Auto Lung Nodule Detection
K201560 · MYN
Samsung Electronics Co., Ltd.
Radiology · 447d
Cleared Aug 30, 2021
StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2
K212103 · MUH
Fona S.R.L
Radiology · 55d
Cleared Aug 27, 2021
MyoSPECT, MyoSpect ES
K212004 · KPS
Ge Healthcare
Radiology · 60d