PSPIX 2 scanner, Imaging Plate Size 0 for PSPIX2 scanner, Imaging Plate Size 1 for PSPIX2 scanner, Imaging Plate Size 2 for PSPIX2 scanner, Imaging Plate Size 3 for PSPIX2 scanner— 510(k) K151053

Substantially Equivalent

Sopro - Acteon Group

FDA 510(k) clearance K151053 for PSPIX 2 scanner, Imaging Plate Size 0 for PSPIX2 scanner, Imaging Plate Size 1 for PSPIX2 scanner, Imaging Plate Size 2 for PSPIX2 scanner, Imaging Plate Size 3 for PSPIX2 scanner, Substantially Equivalent on 2015-07-31. Applicant: Sopro - Acteon Group. Device class: 2.

Clearance details

Applicant
Sopro - Acteon Group
Product code
Code MUH
Device class
Class 2
Regulation
21 CFR 872.1800
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
La Ciotat, FR
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Data sourced from openFDA. This site is unofficial and independent of the FDA.