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

LINEAR ACCELERATOR G-2900

K Number: K771260 · Decision Aug 3, 1977
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
6
Review Days
21

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Basic Information

Device Name
LINEAR ACCELERATOR G-2900
K Number
K771260
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
892.5050
Medical Specialty
Radiology
Decision
Substantially Equivalent
Applicant
Atomic Energy of Canada
Date Received
July 13, 1977
Decision Date
August 3, 1977
Product Code
IYE
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
IYE Accelerator, Linear, Medical

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K850543 THERATRON 780C A RADIONUCLIDE RADIATION THERAPY SY
K837347 LINEAR ACCELERATOR THERAC 25
K837346 MODEL GAMMACELL 1000
K837152 THERAC 25 LINEAR ACCELERATOR
K771096 TELHTHERAPY SIMULATOR AECL-CP, G-3200