DeviceClearance

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.

Clearance details

Applicant
ABBOTT MEDICAL
Product code
Code NQQ
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Westford, MA, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.