PHILIPS PROGRADE; PHILIPS ELEVA WORKSPOT FOR DIGITAL DIAGNOST— 510(k) K141736

Clearance details

Applicant

Philips Medical Systems Dmc GmbH

Product code

Code MQB

Device class

Class 2

Regulation

21 CFR 892.1680

Advisory panel

Radiology

Date received

2014-06-27

Decision date

2014-07-25

Decision

Substantially Equivalent

Clearance type

Special

Location

Hamburg, DE

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K141736.