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
1945–1968 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Jun 17, 2022
ART-PLAN
K220813 · QKB
Therapanacea
Radiology · 88d
Cleared Jun 16, 2022
Wireless Digital Flat Panel Detector
K221345 · MQB
Iray Technology Taicang , Ltd.
Radiology · 38d
Cleared Jun 16, 2022
Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea...
K213504 · JAK
Canon Medical Systems Corporation
Radiology · 227d
Cleared Jun 15, 2022
ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System...
K221448 · IYE
Varian Medical Systems, Inc.
Radiology · 28d
Cleared Jun 15, 2022
SurgiCase Viewer
K213684 · LLZ
Materialise NV
Radiology · 205d
Cleared Jun 14, 2022
Digital Radiography CXDI-Elite, Digital Radiography E1
K221620 · MQB
Canon, Inc.
Radiology · 11d
Cleared Jun 14, 2022
ACUSON Sequoia Diagnostic Ultrasound System
K221500 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 22d
Cleared Jun 13, 2022
iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System
K221081 · IZL
First Source, Inc.
Radiology · 62d
Cleared Jun 10, 2022
Swoop Portable MR Imaging System
K221393 · LNH
Hyperfine, Inc.
Radiology · 28d
Cleared Jun 10, 2022
MediLab
K221065 · LLZ
Sigma Scientific Services, LLC
Radiology · 59d
Cleared Jun 08, 2022
HD60 Series Ultrasound Diagnostic System
K213862 · IYN
Qingdao Hisense Medical Equipment...
Radiology · 180d
Cleared Jun 08, 2022
AIR Recon DL
K213717 · LNH
Ge Medical Systems,Llc (Ge Healthcare)
Radiology · 196d
Cleared Jun 07, 2022
D²RS and D²RS 9090
K221335 · OWB
Stephanix
Radiology · 29d
Cleared Jun 07, 2022
Natural Rubber Latex Ultrasound Transducer Probe Covers
K213087 · ITX
Global Protection Corp.
Radiology · 256d