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 | Device Class | Medical Specialty |
|---|---|---|---|
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | FDA class 2 | Radiology |
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Other Clearances by Atomic Energy of Canada
| K Number | Device Name | ||
|---|---|---|---|
| K850543 | THERATRON 780C A RADIONUCLIDE RADIATION THERAPY SY | May 10, 1985 | Substantially Equivalent |
| K837347 | LINEAR ACCELERATOR THERAC 25 | Jun 24, 1983 | Substantially Equivalent |
| K837346 | MODEL GAMMACELL 1000 | Jun 24, 1983 | Substantially Equivalent |
| K837152 | THERAC 25 LINEAR ACCELERATOR | Mar 22, 1983 | Substantially Equivalent |
| K771260 | LINEAR ACCELERATOR G-2900 | Aug 3, 1977 | Substantially Equivalent |