FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
THERATON 1000E
K Number: K964607
·
Decision May 28, 1997
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
9
Review Days
191
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Basic Information
- Device Name
- THERATON 1000E
- K Number
- K964607
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Theratronics, Inc.
- Date Received
- November 18, 1996
- Decision Date
- May 28, 1997
- Product Code
- IWD
- 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 |
|---|---|---|---|
| IWD | Device, Beam Limiting, Teletherapy, Radionuclide | FDA class 2 | Radiology |
Other Clearances by Theratronics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K983917 | THERATRON ELITE | Dec 4, 1998 | Substantially Equivalent |
| K970236 | THERAPLAN PLUS VERSION 1.2 | Jul 9, 1997 | Substantially Equivalent |
| K964606 | THERATRON 780E | Jun 26, 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 |