OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System— 510(k) K210458

Substantially Equivalent

ABBOTT MEDICAL

FDA 510(k) clearance K210458 for OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System, Substantially Equivalent on 2021-06-08. Applicant: ABBOTT MEDICAL. Device class: 2.

Clearance details

Applicant
ABBOTT MEDICAL
Product code
Code NQQ
Device class
Class 2
Regulation
21 CFR 892.1560
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Westford, MA, US
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