FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE
K Number: K001006
·
Decision Apr 27, 2000
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
47
Applicant Total
7
Review Days
29
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Basic Information
- Device Name
- THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE
- K Number
- K001006
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.5750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mds Nordion
- Date Received
- March 29, 2000
- Decision Date
- April 27, 2000
- Product Code
- IWB
- 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 |
|---|---|---|---|
| IWB | System, Radiation Therapy, Radionuclide | FDA class 2 | Radiology |
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