K250264

SugarBug (1.x)

510(k) number
K250264
Device name
SugarBug (1.x)
Applicant
Bench7, Inc. ND · US
Product code
MYN — Analyzer, Medical Image
Decision date
2025-11-07
Date received
2025-01-29
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Radiology
PDFDownload 510(k) SummaryArchived here · 1.6 MB · U.S. public domain

Also available from FDA: K250264.pdf

Official FDA record: K250264
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.