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
2281–2304 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Aug 23, 2021
6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZF
K212105 · MQB
Pzmedical Technology Co., Ltd.
Radiology · 48d