FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,589 results
2185–2208 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Aug 27, 2021
LOGIQ E10s, LOGIQ Fortis
K211524 · IYN
Ge Healthcare
Radiology · 102d
Cleared Aug 27, 2021
SOMATOM go.Platform Scanners - SOMATOM go.Now, go.Up, go.All, go.Top, SOMATOM...
K211373 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 115d
Cleared Aug 27, 2021
RBknee
K203696 · LLZ
Radiobotics Aps
Radiology · 252d
Cleared Aug 25, 2021
Diagnostic X-ray System/PLX5200A
K212134 · IZL
Nanjing Perlove Medical Equipment...
Radiology · 48d
Cleared Aug 25, 2021
RFA-1717DIG, RFA-1717DIC
K212051 · MQB
Astel, Inc.
Radiology · 56d
Cleared Aug 24, 2021
SKR 3000
K210619 · MQB
Konica Minolta, Inc.
Radiology · 176d
Cleared Aug 23, 2021
IMRIS iMRI 3T V
K212367 · LNH
Deerfield Imaging, Inc.
Radiology · 24d