Cleared Abbreviated

FILM PROCESSOR, MODEL LIFE RAY PRO 2500

K023825 · S.A.I.E.P. S.R.L. · Radiology

Feb 2003

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K023825 is an FDA 510(k) clearance for the FILM PROCESSOR, MODEL LIFE RAY PRO 2500, a Processor, Radiographic-film, Automatic (Class II — Special Controls, product code IXW), submitted by S.A.I.E.P. S.R.L. (Weatherford, US). The FDA issued a Cleared decision on February 12, 2003, 90 days after receiving the submission on November 14, 2002. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1900.

Submission Details

510(k) Number	K023825 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 14, 2002
Decision Date	February 12, 2003
Days to Decision	90 days
Submission Type	Abbreviated
Review Panel	Radiology (RA)
Summary	Summary PDF