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
793–816 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Feb 26, 2025
Ventripoint Medical System Plus (VMS+) 4.0
K241222 · QIH
Ventripoint Diagnostics , Ltd.
Radiology · 301d
Cleared Feb 25, 2025
JLK-AILink
K250348 · LLZ
JLK, Inc.
Radiology · 19d
Cleared Feb 25, 2025
3DXR
K243446 · OWB
GE Medical Systems SCS
Radiology · 111d
Cleared Feb 25, 2025
ART-Plan+ (v.3.0.0)
K242822 · MUJ
Therapanacea Sas
Radiology · 160d
Cleared Feb 24, 2025
ExamVue Apex
K244010 · MQB
Jpi Healthcare Co, Ltd.
Radiology · 60d
Cleared Feb 24, 2025
OncoStudio (OS-01)
K242994 · QKB
Oncosoft. Co., Ltd.
Radiology · 151d
Cleared Feb 21, 2025
Sonio Suspect
K243614 · POK
Sonio
Radiology · 91d
Cleared Feb 21, 2025
Green X 12 SE (PHT-40CHS)
K243088 · OAS
VATECH Co., Ltd.
Radiology · 144d
Cleared Feb 21, 2025
QuickRad
K242838 · LLZ
Aikenist Technologies Pvt, Ltd.
Radiology · 155d
Cleared Feb 21, 2025
ScanDiags Ortho L-Spine MR-Q
K242607 · QIH
Scandiags AG
Radiology · 171d
Cleared Feb 20, 2025
Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7,...
K250214 · IYN
Edan Instruments, Inc.
Radiology · 27d
Cleared Feb 20, 2025
EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)
K242821 · QAS
Ever Fortune.Ai, Co., Ltd.
Radiology · 155d
Cleared Feb 20, 2025
NUSONO Handheld Ultrasound Scanner (NUSONO-C35)
K242681 · IYN
Nurodata, Inc.
Radiology · 167d
Cleared Feb 20, 2025
CaRi-Plaque
K242240 · LLZ
Caristo Diagnostics , Ltd.
Radiology · 205d
Cleared Feb 19, 2025
Brainomix 360 e-Lung
K242411 · JAK
Brainomix Limited
Radiology · 189d
Cleared Feb 14, 2025
BriefCase-Triage
K250248 · QAS
Aidoc Medical , Ltd.
Radiology · 18d
Cleared Feb 14, 2025
AVIEW CAC
K243696 · QIH
Coreline Soft Co., Ltd.
Radiology · 77d
Cleared Feb 14, 2025
Brainomix 360 e-ASPECTS
K243294 · POK
Brainomix Limited
Radiology · 119d
Cleared Feb 14, 2025
Green X 21 (PHT-90CHO)
K243081 · OAS
VATECH Co., Ltd.
Radiology · 137d
Cleared Feb 12, 2025
V8 Diagnostic Ultrasound System
K243702 · IYN
Samsung Medison Co., Ltd.
Radiology · 75d
Cleared Feb 12, 2025
NAEOTOM Alpha.Peak/ NAEOTOM Alpha
K243523 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 90d
Cleared Feb 12, 2025
SubtleHD (1.x)
K243250 · QIH
Subtle Medical, Inc.
Radiology · 120d
Cleared Feb 12, 2025
SureWave Elastography (Q7000225)
K242006 · LNH
Quality Electrodynamics, LLC
Radiology · 218d
Cleared Feb 12, 2025
AspenView
K241425 · LLZ
Aspen Imaging Healthcare, Inc.
Radiology · 268d