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
1513–1536 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 06, 2023
Lumos 3DX
K223780 · EHD
3Dio
Radiology · 202d
Cleared Jul 03, 2023
Axial3D Insight
K222745 · QIH
Axial Medical Printing Limited
Radiology · 294d
Cleared Jun 30, 2023
Pixyl.Neuro
K213253 · LLZ
Pixyl SA
Radiology · 638d
Cleared Jun 29, 2023
XENOVIEW 3.0T Chest Coil
K231647 · MOS
Polarean, Inc.
Radiology · 24d
Cleared Jun 23, 2023
MapRT
K231185 · IYE
Vision Rt, Ltd.
Radiology · 58d
Cleared Jun 23, 2023
VINNO G86,VINNO G86E,VINNO G65,VINNO G65P,VINNO G65E,VINNO G65D,VINNO M86,...
K230160 · IYN
Vinno Technology (Suzhou) Co.,Ltd
Radiology · 155d
Cleared Jun 23, 2023
Radixact Treatment Delivery System
K223159 · IYE
Accuray Incorporated
Radiology · 259d
Cleared Jun 23, 2023
Medisystem Pacs
K223048 · LLZ
Medilab Manutencao E Sitemas Ltda
Radiology · 267d
Cleared Jun 22, 2023
QuickRayPRO
K231202 · MUH
Denterprise International, Inc.
Radiology · 56d
Cleared Jun 22, 2023
Bladder AI (AIBV01)
K230497 · QIH
Exo, Inc.
Radiology · 118d
Cleared Jun 21, 2023
1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF
K231467 · MQB
Rayence Co., Ltd.
Radiology · 30d
Cleared Jun 20, 2023
HepaFatSmart (V2.0.0)
K231459 · LNH
Resonance Health Analysis Services...
Radiology · 32d
Cleared Jun 20, 2023
Voluson SWIFT
K230346 · IYN
Ge Medical Systems Ultrasound &...
Radiology · 132d
Cleared Jun 20, 2023
F3
K222998 · OWB
Acrew Imaging, Inc.
Radiology · 265d
Cleared Jun 17, 2023
VINNO G50, VINNO G55, VINNO M50, VINNO E30, VINNO X5, VINNO X6, VINNO X7,...
K223920 · IYN
Vinno Technology (Suzhou) Co.,Ltd
Radiology · 170d
Cleared Jun 17, 2023
VINNO E20, VINNO E10,VINNO E10P,VINNO E10E, VINNO X1,VINNO X1E,VINNO X1P,...
K223917 · IYN
Vinno Technology (Suzhou) Co.,Ltd
Radiology · 170d
Cleared Jun 16, 2023
SOMATOM Edge Plus, SOMATOM Confidence, SOMATOM Definition Edge, SOMATOM...
K230421 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 120d
Cleared Jun 16, 2023
IB Lab LAMA
K223646 · QIH
Ib Lab GmbH
Radiology · 192d
Cleared Jun 16, 2023
DeepCatch
K223556 · QIH
Medical IP Co., Ltd.
Radiology · 200d
Cleared Jun 13, 2023
CAC Software
K230112 · JAK
Imbio, Inc.
Radiology · 147d
Cleared Jun 09, 2023
M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9...
K230768 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 81d
Cleared Jun 09, 2023
JUSHA-C810G/C810G LCD Monitor, JUSHA-C660/JUSHA-C660G/C660/C660G LCD Monitor
K230728 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 85d
Cleared Jun 09, 2023
Orthopantomograph™ OP 3D LX
K230505 · OAS
Palodex Group OY
Radiology · 105d
Cleared Jun 09, 2023
CT Perfusion V1.0
K223091 · LLZ
Olea Medical
Radiology · 252d