FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

TELHTHERAPY SIMULATOR AECL-CP, G-3200

K Number: K771096 · Decision Jul 1, 1977
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
299
Applicant Total
6
Review Days
11

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Basic Information

Device Name
TELHTHERAPY SIMULATOR AECL-CP, G-3200
K Number
K771096
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
892.1650
Medical Specialty
Radiology
Decision
Substantially Equivalent
Applicant
Atomic Energy of Canada
Date Received
June 20, 1977
Decision Date
July 1, 1977
Product Code
JAA
Advisory Committee
Radiology
Review Advisory Committee
RA
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
JAA System, X-Ray, Fluoroscopic, Image-Intensified

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Other Clearances by Atomic Energy of Canada

K Number Device Name
K850543 THERATRON 780C A RADIONUCLIDE RADIATION THERAPY SY
K837347 LINEAR ACCELERATOR THERAC 25
K837346 MODEL GAMMACELL 1000
K837152 THERAC 25 LINEAR ACCELERATOR
K771260 LINEAR ACCELERATOR G-2900