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
2113–2136 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Feb 04, 2022
Radialis PET Camera
K214062 · KPS
Radialis, Inc.
Radiology · 39d
Cleared Feb 04, 2022
Revolution Ascend
K213938 · JAK
Ge Healthcare Japan Corporation
Radiology · 50d
Cleared Feb 04, 2022
Veuron-Brain-pAb2
K213801 · LLZ
Heuron Co., Ltd.
Radiology · 60d
Cleared Feb 04, 2022
Micro C Medical Imaging System, M01
K212654 · IZL
Oxos Medical, Inc.
Radiology · 165d
Cleared Feb 04, 2022
Magnifico Open, Magnifico MSK
K212419 · LNH
Esaote, S.P.A.
Radiology · 184d
Cleared Feb 04, 2022
smart-sync
K212271 · LNH
Northh Medical GmbH
Radiology · 199d
Cleared Feb 03, 2022
Contour ProtégéAI
K213976 · QKB
Mim Software, Inc.
Radiology · 45d
Cleared Jan 31, 2022
SKR 3000
K213908 · MQB
Konica Minolta, Inc.
Radiology · 48d
Cleared Jan 28, 2022
X-CUBE i8, X-CUBE i9
K213523 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 86d
Cleared Jan 28, 2022
syngo.CT Brain Hemorrhage
K203260 · QAS
Siemens Medical Solutions USA, Inc.
Radiology · 449d
Cleared Jan 24, 2022
DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1
K213780 · MQB
Canon, Inc.
Radiology · 53d
Cleared Jan 24, 2022
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5
K212333 · IYN
Canon Medical Systems Corporation
Radiology · 181d
Cleared Jan 21, 2022
Universal DR 1748
K214030 · MQB
Konica Minolta Healthcare Americas, Inc.
Radiology · 29d
Cleared Jan 20, 2022
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS
K214084 · OAS
Cefla S.C.
Radiology · 24d
Cleared Jan 20, 2022
syngo.CT Extended Functionality
K214019 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Jan 20, 2022
SIGNA PET/MR
K213709 · OUO
Ge Medical Systems, LLC
Radiology · 57d
Cleared Jan 20, 2022
SIGNA Hero
K213668 · LNH
Ge Healthcare (Ge Medical Systems, LLC)
Radiology · 59d
Cleared Jan 19, 2022
3D Bolus Software Application, 3D Brachy Software Application,...
K213438 · MUJ
Adaptiiv
Radiology · 89d
Cleared Jan 19, 2022
Follicle Clarity
K212012 · QIH
Cycle Clarity
Radiology · 205d
Cleared Jan 19, 2022
Caption Interpretation Automated Ejection Fraction Software
K210747 · QIH
Caption Health
Radiology · 313d
Cleared Jan 16, 2022
SIGNA Prime
K211980 · LNH
Ge Healthcare (Tianjin) Company Limited
Radiology · 205d
Cleared Jan 14, 2022
Respiratory Gating for Scanners v2.0
K213927 · JAK
Varian Medical Systems, Inc.
Radiology · 29d
Cleared Jan 14, 2022
Quantib ND
K213737 · LLZ
Quantib B.V.
Radiology · 46d
Cleared Jan 14, 2022
Eclipse II with Smart Noise Cancellation
K213307 · MQB
Carestream Health, Inc.
Radiology · 102d