Cleared Traditional

BLA-800A

K954310 · Toshiba Medical Systems · Radiology
Oct 1995
Decision
33d
Days
Class 2
Risk

About This 510(k) Submission

K954310 is an FDA 510(k) clearance for the BLA-800A, a Device, Beam Limiting, X-ray, Diagnostic (Class II — Special Controls, product code KPW), submitted by Toshiba Medical Systems (Tustin, US). The FDA issued a Cleared decision on October 18, 1995, 33 days after receiving the submission on September 15, 1995. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1610.

Submission Details

510(k) Number K954310 FDA.gov
FDA Decision Cleared SESE
Date Received September 15, 1995
Decision Date October 18, 1995
Days to Decision 33 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code KPW — Device, Beam Limiting, X-ray, Diagnostic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1610