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
1177–1200 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 02, 2024
ECG-less Cardiac
K233750 · JAK
Ge Medical Systems, LLC
Radiology · 132d
Cleared Apr 02, 2024
Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System
K232835 · JAK
Canon Medical Systems Corporation
Radiology · 201d
Cleared Apr 01, 2024
Us2.v2
K233676 · QIH
Eko.Ai Pte Ltd. D/B/A Us2.Ai
Radiology · 137d
Cleared Mar 29, 2024
MAGNETOM Viato.Mobile
K240608 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 25d
Cleared Mar 29, 2024
LCD Monitors C310S, G310S, C316S, G316S, C616W
K240310 · PGY
Shenzhen Beacon Display Technology...
Radiology · 56d
Cleared Mar 29, 2024
AlignRT Plus
K233622 · IYE
Vision Rt, Ltd.
Radiology · 137d
Cleared Mar 29, 2024
AVIEW CAC
K233211 · QIH
Coreline Soft Co., Ltd.
Radiology · 183d
Cleared Mar 29, 2024
LUNA 3D
K232031 · IYE
Lap GmbH Laser Applikationen
Radiology · 266d
Cleared Mar 28, 2024
Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G,...
K240284 · IZL
Shenzhen Browiner Tech Co., Ltd.
Radiology · 56d
Cleared Mar 28, 2024
FDR Visionary Suite
K233719 · KPR
Shimadzu Corporation
Radiology · 128d
Cleared Mar 28, 2024
OEC 3D
K233669 · OXO
Ge Oec Medical Systems, Inc.
Radiology · 134d
Cleared Mar 28, 2024
NAEOTOM Alpha
K233657 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 135d
Cleared Mar 27, 2024
MAMMOMAT B.brilliant
K233539 · MUE
Siemens Medical Solutions USA, Inc.
Radiology · 145d
Cleared Mar 27, 2024
CARPL (CARPL)
K232891 · LLZ
Carpl Ai, Inc.
Radiology · 191d
Cleared Mar 26, 2024
SyMRI
K233733 · LNH
Syntheticmr AB (Publ.)
Radiology · 126d
Cleared Mar 26, 2024
SOMATOM go.Up
K233650 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 133d
Cleared Mar 25, 2024
Cube Navigator
K240620 · LLZ
Medical Templates AG
Radiology · 20d
Cleared Mar 22, 2024
uMR Omega
K240540 · LNH
Shanghai United Imaging Healthcare...
Radiology · 25d
Cleared Mar 22, 2024
syngo.CT Brain Hemorrhage
K232431 · QAS
Siemens Medical Solutions USA, Inc.
Radiology · 224d
Cleared Mar 22, 2024
MAGNETOM Terra
K232322 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 232d
Cleared Mar 22, 2024
Digital Ultrasonic Diagnostic Imaging System (Model: F6)
K231930 · IYN
Guangdong Youkey Medical Co., Ltd.
Radiology · 266d
Cleared Mar 21, 2024
AI-Rad Companion (Pulmonary)
K233753 · JAK
Siemens Healthcare GmbH
Radiology · 120d
Cleared Mar 18, 2024
nCommand Lite System
K233660 · LLZ
Ionic Health
Radiology · 124d
Cleared Mar 18, 2024
X-Clever (ASHK100G)
K233599 · LLZ
Lg Electronics.Inc
Radiology · 130d