FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
THERATRON ELITE
K Number: K983917
·
Decision Dec 4, 1998
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
47
Applicant Total
9
Review Days
30
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Basic Information
- Device Name
- THERATRON ELITE
- K Number
- K983917
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.5750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Theratronics, Inc.
- Date Received
- November 4, 1998
- Decision Date
- December 4, 1998
- 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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Other Clearances by Theratronics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K970236 | THERAPLAN PLUS VERSION 1.2 | Jul 9, 1997 | Substantially Equivalent |
| K964606 | THERATRON 780E | Jun 26, 1997 | Substantially Equivalent |
| K964607 | THERATON 1000E | May 28, 1997 | Substantially Equivalent |
| K954679 | THERAPLAN PLUS | Nov 8, 1996 | Substantially Equivalent |
| K940237 | THERAPLAN V05B/ TP-11 V09B | Jul 26, 1994 | Substantially Equivalent |
| K922276 | THERAC 25 | May 25, 1994 | Substantially Equivalent |
| K894165 | THERATRON 1000 | Feb 1, 1990 | Substantially Equivalent |
| K820782 | THERATRONIC STIMULATOR | Jun 3, 1982 | Substantially Equivalent |