MG-1001 TUBE HOUSING ASSEMBLY— 510(k) K921316

Name: FDA 510(k) clearance K921316
Creator: U.S. Food and Drug Administration
Published: 1992-06-22

Substantially Equivalent

Magma Corp.

FDA 510(k) clearance K921316 for MG-1001 TUBE HOUSING ASSEMBLY, Substantially Equivalent on 1992-06-22. Applicant: Magma Corp.. Device class: 1.

Clearance details

Applicant: Magma Corp.
Product code: Code ITY
Device class: Class 1
Regulation: 21 CFR 892.1760
Advisory panel: Radiology
Date received: 1992-03-17
Decision date: 1992-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Teaneck, NJ, US

Download summary PDF View on FDA.gov ↗

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K000052 — X-RAY MONOBLOCK, MONOBLOCK XRS-60-3302000-02-10
K933162 — MRX-7501993-10-07
K923094 — MOLYBDENUM1993-03-04
K923141 — PHILIPS PRE-FILTER OPTION1993-01-21
K921129 — MRX-7001992-10-05

Adverse events under product code ITY

product code ITY

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.