RMS-1000 A.K.A. RAYTHEON MEDICAL SYSTEMS-1000— 510(k) K853395

Name: FDA 510(k) clearance K853395
Creator: U.S. Food and Drug Administration
Published: 1985-11-01

Substantially Equivalent

Raytheon Medical Systems

FDA 510(k) clearance K853395 for RMS-1000 A.K.A. RAYTHEON MEDICAL SYSTEMS-1000, Substantially Equivalent on 1985-11-01. Applicant: Raytheon Medical Systems. Device class: 2.

Clearance details

Applicant: Raytheon Medical Systems
Product code: Code IZH
Device class: Class 2
Regulation: 21 CFR 892.1710
Advisory panel: Radiology
Date received: 1985-08-12
Decision date: 1985-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melrose Park, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IZH

view all

K203509 — SMART FINDER2021-07-14
K202294 — Affirm Contrast Biopsy2020-10-05
K191495 — Biopsy Positioner2019-07-03
K161575 — Affirm Lateral Arm Upright Biopsy Accessory2016-08-10
K161920 — Comfort Cover2016-07-15

More clearances from Raytheon Medical Systems

view all

K851644 — SPECTRUM 150 DT1985-05-21

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