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
2089–2112 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 02, 2022
Dental Image Plate Scanner, Model DFC-4T-SMART
K214091 · MUH
Hefei Dentafilm Medical Equipment...
Radiology · 64d
Cleared Mar 02, 2022
Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph
K213579 · OAS
Fona S.R.L
Radiology · 112d
Cleared Mar 02, 2022
NovaGuide 2 Intelligent Ultrasound
K213279 · IYN
Novasignal Corporation
Radiology · 152d
Cleared Mar 01, 2022
BoneView
K212365 · QBS
Gleamer
Radiology · 214d
Cleared Mar 01, 2022
Digimamo D
K210151 · MUE
Vmi Tecnologias Ltda
Radiology · 404d
Cleared Feb 25, 2022
MAGNETOM Vida with syngo MR XA50A
K213693 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 94d
Cleared Feb 25, 2022
OmniTom Elite
K211711 · JAK
Neurologica Corporation, A Subsidiary...
Radiology · 267d
Cleared Feb 24, 2022
Annalise Enterprise CXR Triage Pneumothorax
K213941 · QFM
Annalise-Ai
Radiology · 70d
Cleared CT Feb 24, 2022
Epione
K211645 · JAK
Quantum Surgical Sas
Radiology · 272d
Cleared Feb 23, 2022
EzOrtho v1.3
K220003 · LLZ
Ewoosoft Co., Ltd.
Radiology · 50d
Cleared Feb 18, 2022
Deep Learning Image Reconstruction
K213999 · JAK
Ge Medical Systems, LLC
Radiology · 59d
Cleared Feb 18, 2022
Viz ANEURYSM, Viz ANX
K213319 · QFM
Viz. Ai, Inc.
Radiology · 137d
Cleared Feb 18, 2022
ExamVue Duo
K213057 · KPR
Jpi Healthcare Co, Ltd.
Radiology · 149d
Cleared Feb 18, 2022
Multitom Rax with True2scale Body Scan Option
K212212 · OWB
Siemens Medical Solutions
Radiology · 218d
Cleared Feb 18, 2022
Pocket Ultrasound System
K211746 · IYN
Guangdong Youkey Medical Co., Ltd.
Radiology · 256d
Cleared Feb 17, 2022
Digital Intraoral X-ray Sensor
K220277 · MUH
Shenzhen Xpectvision Technology Co.,...
Radiology · 17d
Cleared Feb 17, 2022
Voluson P6, Voluson P8
K213689 · IYN
Ge Healthcare
Radiology · 86d
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