XRE COLLIMATOR— 510(k) K960998

Substantially Equivalent

Xre Corp.

FDA 510(k) clearance K960998 for XRE COLLIMATOR, Substantially Equivalent on 1996-04-03. Applicant: Xre Corp.. Device class: 2.

Clearance details

Applicant: Xre Corp.
Product code: Code IZW
Device class: Class 2
Regulation: 21 CFR 892.1610
Advisory panel: Radiology
Date received: 1996-03-12
Decision date: 1996-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Littleton, MA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Xre Corp.

K973744 — UNICATH SP BI-PLANE (MODEL M269 & M289)1997-12-29
K961193 — FULL FRAME ZOOM SYSTEM1996-06-17
K945449 — UNICATH LLU ANGIOGRAPHIC SYSTEM1995-02-27
K936002 — CINEMAC QAS1994-09-09
K933460 — DVFX, MODEL M2561994-04-07

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