Cleared Traditional

K781473 - BUCKY WALL STAND (FDA 510(k) Clearance)

Sep 1978
Decision
14d
Days
Class 2
Risk

K781473 is an FDA 510(k) clearance for the BUCKY WALL STAND. This device is classified as a System, X-ray, Stationary (Class II - Special Controls, product code KPR).

Submitted by Philips Medical Systems (Cleveland), Inc. (Walker, US). The FDA issued a Cleared decision on September 11, 1978, 14 days after receiving the submission on August 28, 1978.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K781473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1978
Decision Date September 11, 1978
Days to Decision 14 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary

Device Classification

Product Code KPR — System, X-ray, Stationary
Device Class Class II - Special Controls
CFR Regulation 21 CFR 892.1680

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