TOSHIBA, SMIT ROENTGEN— 510(k) K870071

Name: FDA 510(k) clearance K870071
Creator: U.S. Food and Drug Administration
Published: 1987-01-21

Substantially Equivalent

North American Imaging, Inc.

FDA 510(k) clearance K870071 for TOSHIBA, SMIT ROENTGEN, Substantially Equivalent on 1987-01-21. Applicant: North American Imaging, Inc.. Device class: 1.

Clearance details

Applicant: North American Imaging, Inc.
Product code: Code ITY
Device class: Class 1
Regulation: 21 CFR 892.1760
Advisory panel: Radiology
Date received: 1987-01-08
Decision date: 1987-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monument, CO, US

Download summary PDF View on FDA.gov ↗

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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.