Cleared Traditional

TRANS X-1000

K945635 · Canon USA, Inc. · Radiology
Feb 1995
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K945635 is an FDA 510(k) clearance for the TRANS X-1000, a Changer, Radiographic Film/cassette (Class II — Special Controls, product code KPX), submitted by Canon USA, Inc. (Lake Success, US). The FDA issued a Cleared decision on February 1, 1995, 77 days after receiving the submission on November 16, 1994. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1860.

Submission Details

510(k) Number K945635 FDA.gov
FDA Decision Cleared SESE
Date Received November 16, 1994
Decision Date February 01, 1995
Days to Decision 77 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code KPX — Changer, Radiographic Film/cassette
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1860

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