PACS EQUIPMENT— 510(k) K943994

Substantially Equivalent

Rstar Image Management System

FDA 510(k) clearance K943994 for PACS EQUIPMENT, Substantially Equivalent on 1995-05-12. Applicant: Rstar Image Management System. Device class: 1.

Clearance details

Applicant: Rstar Image Management System
Product code: Code LMD
Device class: Class 1
Regulation: 21 CFR 892.2020
Advisory panel: Radiology
Date received: 1994-08-16
Decision date: 1995-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LMD

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K992352 — ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.01999-09-29
K991537 — SAMSUNG RAYPAX SYSTEM1999-07-06

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