WBA - I.R.I.S.— 510(k) K842895

Substantially Equivalent

Siemens Gammasonics, Inc.

FDA 510(k) clearance K842895 for WBA - I.R.I.S., Substantially Equivalent on 1984-08-27. Applicant: Siemens Gammasonics, Inc.. Device class: 1.

Clearance details

Applicant: Siemens Gammasonics, Inc.
Product code: Code JAM
Device class: Class 1
Regulation: 21 CFR 892.1330
Advisory panel: Radiology
Date received: 1984-07-23
Decision date: 1984-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JAM

K841996 — MAXICAMERA 400T W/BODY CONTOUR TOMOGRA1984-07-16
K770530 — CLEON IMAGER1977-04-05

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K933256 — FAN BEAM COLLIMATOR1993-10-29
K920319 — SIENET IMAGE DISPLAY WORKSTATIONS, IMAGE ACQUISITI1992-10-20
K923582 — SIENET CAMERA SERVER1992-10-14

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