Cleared Traditional

K921316 - MG-1001 TUBE HOUSING ASSEMBLY (FDA 510(k) Clearance)

K921316 · Magma Corp. · Radiology device

Jun 1992

Decision

97d

Days

Class 1

Risk

K921316 is an FDA 510(k) clearance for the MG-1001 TUBE HOUSING ASSEMBLY. This device is classified as a Assembly, Tube Housing, X-ray, Diagnostic (Class I - General Controls, product code ITY).

Submitted by Magma Corp. (Teaneck, US). The FDA issued a Cleared decision on June 22, 1992, 97 days after receiving the submission on March 17, 1992.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1760.

Submission Details

510(k) Number	K921316 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 17, 1992
Decision Date	June 22, 1992
Days to Decision	97 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement