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
1057–1080 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 30, 2024
WERAY
K241963 · EHD
Picopack Co., Ltd.
Radiology · 27d
Cleared Jul 26, 2024
Symbia SPECT and SPECT/CT Systems
K241898 · KPS
Siemens Healthineers
Radiology · 28d
Cleared Jul 26, 2024
EXSYS DEXi (EXSYS DEXi-D401S-FRM)
K233530 · KPR
DRTECH Corporation
Radiology · 267d
Cleared Jul 24, 2024
Non-Sterile Ultrasound Transmission Gels
K241789 · MUI
Hony Medical Co., Ltd.
Radiology · 33d
Cleared Jul 24, 2024
ExacTrac Dynamic (2.0)
K240431 · IYE
Brainlab AG
Radiology · 161d
Cleared Jul 23, 2024
EzDent-i / E2 / Prora View / Smart M Viewer (v3.5)
K241114 · LLZ
Ewoosoft Co., Ltd.
Radiology · 92d
Cleared Jul 23, 2024
TE Air Diagnostic Ultrasound System
K240906 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 112d
Cleared Jul 22, 2024
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic...
K240704 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 130d
Cleared Jul 22, 2024
neo315
K231133 · LNH
Neoscan Solution GmbH
Radiology · 458d
Cleared Jul 18, 2024
vRad Viewer
K241879 · LLZ
Virtual Radiologic Corporation
Radiology · 20d
Cleared Jul 17, 2024
MICSI-RMT
K241121 · LLZ
Microstructure Imaging, Inc.
Radiology · 85d
Cleared Jul 17, 2024
Rayvolve
K240845 · QBS
Azmed Sas
Radiology · 112d
Cleared Jul 17, 2024
Vitrea Software Package, VSTP-002A V2.0
K240705 · LLZ
Canon Medical Systems Corporation
Radiology · 125d
Cleared Jul 16, 2024
RadiForce RX670
K241441 · PGY
Eizo Corporation
Radiology · 55d
Cleared Jul 16, 2024
Swoop® Portable MR Imaging® System
K240944 · LNH
Hyperfine, Inc.
Radiology · 102d
Cleared Jul 15, 2024
NeuroLF (Basic)
K241751 · KPS
Positrigo AG
Radiology · 27d
Cleared Jul 12, 2024
BriefCase-Triage
K241727 · QAS
Aidoc Medical , Ltd.
Radiology · 28d
Cleared Jul 12, 2024
HiRise (1040-230)
K241713 · JAK
Curvebeam, LLC
Radiology · 28d
Cleared Jul 12, 2024
Acorn 3D Software (AC-SEG-4009)
K234009 · QIH
Mighty Oak Medical
Radiology · 206d
Cleared Jul 12, 2024
RUS
K233457 · QIH
Hutom, Inc.
Radiology · 266d
Cleared Jul 11, 2024
SubtleSYNTH (1.x)
K241329 · QIH
Subtle Medical, Inc.
Radiology · 62d
Cleared Jul 10, 2024
AOS Interstitial Templates, Needles, and Accessories
K233628 · JAQ
Alpha-Omega Services, Inc.
Radiology · 240d
Cleared Jul 05, 2024
DUO1 and DUO2
K241649 · MUH
Zinnovi, Inc.
Radiology · 28d
Cleared Jul 05, 2024
LifeRay Intraoral Handheld X-ray System
K241305 · EHD
Lucas Lifecare
Radiology · 57d