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
1921–1944 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 08, 2022
Transcranial Doppler Ultrasound System
K213009 · IYN
Shenzhen Delica Medical Equipment...
Radiology · 291d
Cleared Jul 08, 2022
ProstatID
K212783 · QDQ
Scanmed, LLC
Radiology · 310d
Cleared Jul 06, 2022
Functional MR V1.0
K221426 · LLZ
Olea Medical S.A.S.
Radiology · 51d
Cleared Jul 01, 2022
i_ Field 1.5T Superconducting Magnetic Resonance Imaging System
K221025 · LNH
Mri Division,Beijing Wandong Medical...
Radiology · 86d
Cleared Jul 01, 2022
Bladder Scanner, Model Name:M5
K213488 · IYO
Suzhou Peaksonic Medical Technology...
Radiology · 242d
Cleared Jun 29, 2022
Flat Panel Detector
K221714 · MQB
Iray Technology Taicang , Ltd.
Radiology · 16d
Cleared Jun 29, 2022
CLAROX
K221286 · EHD
Vsi Co., Ltd.
Radiology · 57d
Cleared Jun 29, 2022
V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System
K220975 · IYN
Samsung Medison Co., Ltd.
Radiology · 86d
Cleared Jun 29, 2022
ARTIS icono (VE21) System
K220432 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 134d
Cleared Jun 29, 2022
ARTIS pheno (VE21) System
K220409 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 135d
Cleared Jun 27, 2022
DT-703
K221233 · EHD
Ecotron Co., Ltd.
Radiology · 59d
Cleared Jun 27, 2022
Venue
K220851 · IYN
GE Medical Systems
Radiology · 96d
Cleared Jun 27, 2022
Venue Fit
K220848 · IYN
GE Medical Systems
Radiology · 96d
Cleared Jun 24, 2022
MAGNETOM Free.Max, MAGNETOM Free.Star
K220575 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 116d
Cleared Jun 24, 2022
FlexBoardTM, EagleBoardTM, BreastBoard SXTM
K213439 · IYE
Macromedics BV
Radiology · 242d
Cleared Jun 23, 2022
Axial3D Cloud Segmentation Service
K221511 · LLZ
Axial Medical Printing Limited
Radiology · 30d
Cleared Jun 23, 2022
Ultrasound System SONIMAGE MX1
K220993 · IYN
Konica Minolta, Inc.
Radiology · 80d
Cleared Jun 23, 2022
CoLumbo
K220497 · QIH
Smart Soft Healthcare AD
Radiology · 121d
Cleared Jun 22, 2022
HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)
K221008 · MUH
Shanghai Handy Medical Equipment Co.,...
Radiology · 78d
Cleared Jun 21, 2022
Venue Go
K220800 · IYN
GE Medical Systems Ultrasound and...
Radiology · 95d
Cleared Jun 21, 2022
Syngo Carbon Space VA20A
K213665 · LLZ
Siemens Healthcare GmbH
Radiology · 211d
Cleared Jun 17, 2022
ElucidVivo A.3
K221463 · LLZ
Elucid Bioimaging, Inc.
Radiology · 29d
Cleared Jun 17, 2022
ARIA Radiation Therapy Management (v16.1 MR3)
K221408 · IYE
Varian Medical Systems, Inc.
Radiology · 32d
Cleared Jun 17, 2022
RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System
K221117 · IYN
Samsung Medison Co., Ltd.
Radiology · 60d