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

Name: FDA 510(k) clearance K860504
Creator: U.S. Food and Drug Administration
Published: 1986-04-04

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.. Device class: 1.

Clearance details

Applicant: Victoreen, Inc.
Product code: Code ITY
Device class: Class 1
Regulation: 21 CFR 892.1760
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 ↗

Recent devices under product code ITY

view all

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

More clearances from Victoreen, Inc.

view all

K982937 — MODEL 580-006 RADIATION THERAPY IONIZATION CHAMBER1998-11-19
K974112 — VACUDAP, MODEL 2000, 20011998-01-29
K973960 — MODEL 37-1851998-01-14
K964952 — VERIDOSE V (FIVE), MODEL NUMBER 37-7051997-07-21
K964785 — VERIDOSE DIODES1997-06-13

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.