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
2041–2064 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Feb 16, 2022
14HQ901G-B
K214044 · MQB
Lg Electronics.Inc
Radiology · 51d
Cleared Feb 11, 2022
SIGNA Artist Evo
K213603 · LNH
Ge Healthcare (Tianjin) Company Limited
Radiology · 88d
Cleared Feb 11, 2022
ACUSON P500 Ultrasound System
K213487 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 105d
Cleared Feb 11, 2022
EzRay M18 (Model: VMX-P400)
K213462 · IZL
VATECH Co., Ltd.
Radiology · 107d
Cleared Feb 11, 2022
ArtUs
K211248 · IYN
Telemed
Radiology · 291d
Cleared Feb 08, 2022
Rapid
K213165 · LLZ
Ischemaview, Inc.
Radiology · 133d
Cleared Feb 04, 2022
Digital Radiography CXDI-Pro, Digital Radiography D1
K220098 · MQB
Canon, Inc.
Radiology · 23d
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