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
745–768 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 04, 2025
HeartFocus (V.1.1.1)
K242807 · QJU
Deski
Radiology · 199d
Cleared Apr 04, 2025
DeepFoqus (DeepFoqus-Accelerate)
K241982 · QIH
Foqus Technologies, Inc.
Radiology · 273d
Cleared Apr 04, 2025
RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation...
K240398 · MUJ
RaySearch Laboratories AB (PUBL)
Radiology · 420d
Cleared Apr 03, 2025
Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic...
K243298 · IYN
Carbon (Shenzhen) Medical Device Co.,...
Radiology · 167d
Cleared Apr 03, 2025
syngo Dynamics (Version VA41D)
K242551 · QIH
Siemens Healthcare GmbH
Radiology · 219d
Cleared Apr 02, 2025
Hi-D Imaging 4TAVR
K241984 · QIH
Hi-D Imaging AG
Radiology · 268d
Cleared Apr 01, 2025
MR Contour DL
K242925 · QKB
Ge Healthcare
Radiology · 189d
Cleared Mar 31, 2025
Digital Color Doppler Ultrasound Imaging System (Apogee C1)
K243178 · IYN
Shantou Institute of Ultrasonic...
Radiology · 182d
Cleared Mar 31, 2025
TribusConnect
K242166 · QIH
Tribusmed Beheer BV
Radiology · 250d
Cleared Mar 28, 2025
ImagingRing m (Version 2.0)
K234067 · OWB
Medphoton GmbH
Radiology · 462d
Cleared Mar 27, 2025
Salix Central
K243038 · QIH
Artrya Limited
Radiology · 181d
Cleared Mar 27, 2025
V5med Lung AI
K242919 · OEB
V5med, Inc.
Radiology · 184d
Cleared Mar 27, 2025
AI-Rad Companion Organs RT
K242745 · QKB
Siemens Healthcare GmbH
Radiology · 197d
Cleared Mar 26, 2025
Rayvolve LN
K243831 · MYN
AZmed
Radiology · 103d
Cleared Mar 21, 2025
Rayvolve PTX-PE
K243808 · QFM
AZmed
Radiology · 100d
Cleared Mar 20, 2025
brAIn™ Shoulder Positioning
K243292 · LLZ
Avatar Medical
Radiology · 153d
Cleared Mar 20, 2025
EXPD 114
K242770 · MQB
DRTECH Corporation
Radiology · 188d
Cleared Mar 20, 2025
Vent Creativity Knee v1.0 (Hermes)
K241961 · QIH
Vent Creativity
Radiology · 260d
Cleared Mar 19, 2025
DSPS-Prominent® baseplate, MR (113820)
K250429 · IYE
Macromedics BV
Radiology · 33d
Cleared Mar 19, 2025
PeekMed web
K250042 · QIH
Peek Health, S.A.
Radiology · 70d
Cleared Mar 19, 2025
AVIEW
K243689 · QIH
Coreline Soft Co., Ltd.
Radiology · 110d
Cleared Mar 19, 2025
EXPD 4343N1
K243443 · MQB
DRTECH Corporation
Radiology · 133d
Cleared Mar 18, 2025
Lux HD 35 Detector (Lux HD 35)
K243556 · MQB
Iray Imaging Technology (Haining)...
Radiology · 120d
Cleared Mar 18, 2025
QP-Prostate® CAD
K242683 · QDQ
Quibim S.L.
Radiology · 193d