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 ×
15,695 results
2089–2112 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 10, 2022
Smile-100 System
K212965 · LHQ
Niramai Health Analytix Private Limited
Radiology · 175d
Cleared Mar 09, 2022
ZEN-2090 Turbo
K211780 · OWB
Genoray Co., Ltd.
Radiology · 273d
Cleared Mar 07, 2022
syngo.CT Applications
K220450 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 18d
Cleared Mar 04, 2022
TE Air Diagnostic Ultrasound System
K220051 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 57d
Cleared Mar 04, 2022
Skanmobile, Skanmobile-Dr
K212940 · IZL
Skanray Technologies Limited
Radiology · 170d
Cleared Mar 04, 2022
Second Opinion
K210365 · MYN
Pearl, Inc.
Radiology · 389d
Cleared Mar 03, 2022
MR Elastography
K220018 · LNH
Canon Medical Systems Corporation
Radiology · 57d
Cleared Mar 03, 2022
Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed...
K213516 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 120d
Cleared Mar 03, 2022
nordicDSC
K212720 · LLZ
Nordicneurolab AS
Radiology · 188d
Cleared Mar 03, 2022
OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with...
K211658 · MOS
Noras Mri Products GmbH
Radiology · 279d
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