FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,589 results
697–720 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Feb 11, 2025
Vivid T9/Vivid T8
K243628 · IYN
GE Medical Systems Ultrasound and...
Radiology · 78d
Cleared Feb 11, 2025
Vivid iq
K243620 · IYN
GE Medical Systems Ultrasound and...
Radiology · 81d
Cleared Feb 10, 2025
Ultrasound Workspace (UWS 6.0)
K241659 · QIH
Philips Ultrasound, LLC
Radiology · 245d
Cleared Feb 07, 2025
Identify (4.0)
K242957 · IYE
Varian Medical Systems, Inc.
Radiology · 135d
Cleared Feb 06, 2025
EPIQ Series Diagnostic Ultrasound System
K243794 · IYN
Philips Ultrasound, LLC
Radiology · 58d
Cleared Feb 05, 2025
BoneMetrics (US)
K241593 · QIH
Gleamer Sas
Radiology · 247d
Cleared Feb 04, 2025
rTOP
K243333 · LLZ
Roclub GmbH
Radiology · 103d