.DECIMAL PHOTON BLOCK— 510(k) K123015

Substantially Equivalent

.Decimal, Inc.

FDA 510(k) clearance K123015 for .DECIMAL PHOTON BLOCK, Substantially Equivalent on 2012-11-21. Applicant: .Decimal, Inc.. Device class: 2.

Clearance details

Applicant: .Decimal, Inc.
Product code: Code IXI
Device class: Class 2
Regulation: 21 CFR 892.5710
Advisory panel: Radiology
Date received: 2012-09-28
Decision date: 2012-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sanford, FL, US

Download summary PDF View on FDA.gov ↗

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