36-101 XDS111 XENON DELIVERY/TRAP SYSTEM— 510(k) K860504

Substantially Equivalent

Victoreen, Inc.

FDA 510(k) clearance K860504 for 36-101 XDS111 XENON DELIVERY/TRAP SYSTEM, Substantially Equivalent on 1986-04-04. Applicant: Victoreen, Inc..

Clearance details

Applicant: Victoreen, Inc.
Product code: Code ITY
Advisory panel: Radiology
Date received: 1986-02-11
Decision date: 1986-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carle Place, NY, US

Download summary PDF View on FDA.gov ↗

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.