X-RAY TUBE HOUSING ASSEMBLY POLARIX II GEN/XO 110— 510(k) K910308

Name: FDA 510(k) clearance K910308
Creator: U.S. Food and Drug Administration
Published: 1991-03-27

Substantially Equivalent

Inmark Corp.

FDA 510(k) clearance K910308 for X-RAY TUBE HOUSING ASSEMBLY POLARIX II GEN/XO 110, Substantially Equivalent on 1991-03-27. Applicant: Inmark Corp.. Device class: 1.

Clearance details

Applicant: Inmark Corp.
Product code: Code ITY
Device class: Class 1
Regulation: 21 CFR 892.1760
Advisory panel: Radiology
Date received: 1991-01-24
Decision date: 1991-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwalk, CT, US

Download summary PDF View on FDA.gov ↗

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

More clearances from Inmark Corp.

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K910276 — X-RAY TUBE HOUSING ASSEMBLY SOREDEX DC/CIR 511991-03-06
K894742 — RELOADING OF X-RAY TUBE HOUSING ASSEM., VARIOUS1989-10-27
K894413 — X-RAY TUBE HOUSING ASSEMBLY, VARIOUS MODELS1989-09-22

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.