510(k) clearances

VenusCT

Linatech, LLC · Radiology

K260510Substantially EquivalentTraditionalSFV
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Third party flag
N
City
Sunnyvale
Advisory committee description
Radiology
Address 1
1294 Kifer Rd., #705
Statement or summary
Summary
Product code
SFV
Zip code
94086
Applicant
Linatech, LLC
Decision date
2026-10-19
Decision code
SESE
Country code
US
Device name
VenusCT
Advisory committee
RA
Contact
Jonathan Yao
K number
K260510
State
CA
Date received
2026-02-17
Review advisory committee
RA
Postal code
94086
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
X-Ray, Computed Tomography, Cone-Beam
Medical specialty description
Radiology
Regulation number
892.1750
Device class
2
Registration number
3009154005, 8043728
FEI number
3009154005, 3002807903
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.