Cleared Traditional

K023613 - AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036
(FDA 510(k) Clearance)

K023613 · Alphatek Corp. · Radiology

Jan 2003

Decision

87d

Days

Class 2

Risk

K023613 is an FDA 510(k) clearance for the AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036. This device is classified as a Processor, Radiographic-film, Automatic (Class II — Special Controls, product code IXW).

Submitted by Alphatek Corp. (Broadview, US). The FDA issued a Cleared decision on January 23, 2003, 87 days after receiving the submission on October 28, 2002.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1900.

Submission Details

510(k) Number	K023613 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 28, 2002
Decision Date	January 23, 2003
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement