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
1369–1392 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 26, 2023
TE Air Diagnostic Ultrasound System
K231685 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 139d
Cleared Oct 25, 2023
Rapid SDH
K232436 · QAS
Ischemaview, Inc.
Radiology · 72d
Cleared Oct 25, 2023
AcuityUDR
K231995 · KPR
Radmedix, LLC
Radiology · 112d
Cleared Oct 25, 2023
K3900 Ultrasound Imaging System
K230511 · IYO
Maui Imaging
Radiology · 243d
Cleared Oct 24, 2023
16 Breast Coil
K233348 · MOS
Philips Medical System Nederlands B.V.
Radiology · 25d
Cleared Oct 24, 2023
spineEOS
K232086 · LLZ
Eos Imaging
Radiology · 103d
Cleared Oct 24, 2023
Aco Apache Ultrasound System
K231509 · IYN
Aco Healthcare Co., Ltd.
Radiology · 152d
Cleared Oct 23, 2023
AI-Rad Companion Brain MR
K232305 · QIH
Siemens Medical Solutions U.S.A.
Radiology · 83d
Cleared Oct 23, 2023
Ultrasound System 1300
K231764 · IYN
Bk Medical Aps
Radiology · 129d
Cleared Oct 23, 2023
MAGNETOM Vida
K231560 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 146d
Cleared Oct 20, 2023
TuxDeluxe (Size 1 6100B, Size 2 6101B)
K232552 · MUH
Tuxedo Imaging, LLC
Radiology · 58d
Cleared Oct 20, 2023
Digital Wireless Intraoral X-Ray Sensor
K230998 · MUH
Iray Imaging Technology (Haining)...
Radiology · 196d
Cleared Oct 20, 2023
Sonix Health
K230209 · QIH
Ontact Health Co., Ltd.
Radiology · 268d
Cleared Oct 20, 2023
R2GATE Lite TM
K223909 · LLZ
Megagen Implant Co., Ltd.
Radiology · 295d
Cleared Oct 19, 2023
CombiDiagnost R90
K232910 · JAA
Philips Medical Systems Dmc GmbH
Radiology · 30d
Cleared Oct 18, 2023
EConsole1
K231225 · LLZ
DRTECH Corporation
Radiology · 173d
Cleared Oct 16, 2023
Ikshana
K230249 · LLZ
Immersivetouch
Radiology · 259d
Cleared Oct 13, 2023
Veuron-Brain-pAb3
K231642 · LLZ
Heuron Co., Ltd.
Radiology · 130d
Cleared Oct 13, 2023
SpotLight/SpotLight Duo (with DLIR option)
K230370 · JAK
Arineta , Ltd.
Radiology · 245d
Cleared Oct 12, 2023
Scenaria View 4.2
K231574 · JAK
Fujifilm Healthcare Americas Corporation
Radiology · 134d
Cleared Oct 12, 2023
Artemis, Artemis TPO, Artemis MX
K222222 · QTZ
Eigen
Radiology · 444d
Cleared Oct 11, 2023
Synq Software Version 1.3
K232981 · LNH
Synaptive Medical, Inc.
Radiology · 20d
Cleared Oct 11, 2023
Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR
K232344 · OWB
GE Medical Systems SCS
Radiology · 68d
Cleared Oct 11, 2023
NeuViz 128 Multi-Slice CT Scanner System
K230220 · JAK
Neusoft Medical Systems Co., Ltd.
Radiology · 258d