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
985–1008 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 01, 2024
GM85
K242651 · IZL
Samsung Electronics Co., Ltd.
Radiology · 27d
Cleared Oct 01, 2024
MuscleView
K241331 · LNH
Springbok, Inc.
Radiology · 144d
Cleared Oct 01, 2024
LungVision
K240943 · QIH
Bodyvision Medical , Ltd.
Radiology · 179d
Cleared Sep 27, 2024
JBS-LVO
K241480 · QAS
JLK, Inc.
Radiology · 126d
Cleared Sep 27, 2024
CAC (gated) Algorithm
K240369 · JAK
BunkerHill Health
Radiology · 233d
Cleared Sep 24, 2024
uAI Easy Triage ICH
K242292 · QAS
Shanghai United Imaging Intelligence...
Radiology · 53d
Cleared Sep 23, 2024
EConsole2
K240243 · LLZ
DRTECH Corporation
Radiology · 237d
Cleared Sep 20, 2024
SuperSonic HepaVu
K242223 · IYN
Supersonic Imagine
Radiology · 53d
Cleared Sep 20, 2024
PIUR tUS Infinity
K240036 · QIH
Piur Imaging GmbH
Radiology · 259d
Cleared Sep 20, 2024
ERI Portable X-ray System (CVX-air)
K234108 · IZL
Energy Resources International Co., Ltd.
Radiology · 268d
Cleared Sep 19, 2024
GF85 (models GF85-3P, GF85-SP)
K242478 · KPR
Samsung Electronics Co., Ltd.
Radiology · 29d
Cleared Sep 19, 2024
Sterile and Non-Sterile Ultrasonic Coupling Agent
K242167 · MUI
Anhui Deepblue Medical Technology...
Radiology · 57d
Cleared Sep 18, 2024
EdgeLife Handheld Wireless Ultrasound System (E8200)
K234153 · IYN
Edgelife Technologies, LLC
Radiology · 264d
Cleared Sep 16, 2024
TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10...
K241201 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 139d
Cleared Sep 12, 2024
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900,...
K241582 · IYN
Canon Medical Systems Corporation
Radiology · 101d
Cleared Sep 12, 2024
Elucid PlaqueIQ
K241524 · LLZ
Elucid Bioimaging, Inc.
Radiology · 106d
Cleared Sep 12, 2024
MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8...
K241432 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 114d
Cleared Sep 12, 2024
Constellation (CON-001)
K241280 · QIH
Q Bio, Inc.
Radiology · 128d
Cleared Sep 12, 2024
Orthopantomograph™ OP 3D LX (PAN 3D)
K241249 · OAS
Palodex Group OY
Radiology · 132d
Cleared Sep 12, 2024
CINA-CSpine
K240942 · QAS
Avicenna.Ai
Radiology · 160d
Cleared Sep 11, 2024
FETOLY-HEART
K241380 · IYN
Diagnoly
Radiology · 119d
Cleared Sep 11, 2024
Ultrasound Imaging System (LK128L)
K241161 · IYN
Leltek, Inc.
Radiology · 138d
Cleared Sep 10, 2024
LumiNE US
K240094 · QIH
Augmedit B.V.
Radiology · 242d
Cleared Sep 09, 2024
Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF)
K242394 · MQB
Rayence Co., Ltd.
Radiology · 27d