FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
THERATRON 1000
K Number: K894165
·
Decision Feb 1, 1990
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
47
Applicant Total
9
Review Days
230
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- THERATRON 1000
- K Number
- K894165
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Theratronics, Inc.
- Date Received
- June 16, 1989
- Decision Date
- February 1, 1990
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IWB), ordered by most recent decision date.
Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon); Leksell Gamma Knife® (Perfexion)
FDA 510(k)
FDA Class 2
·Radiology
Leksell GammaPlan (LGP)
FDA 510(k)
FDA Class 2
·Radiology
Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)
FDA 510(k)
FDA Class 2
·Radiology
TaiChiC
FDA 510(k)
FDA Class 2
·Radiology
Akesis Galaxy RTi
FDA 510(k)
FDA Class 2
·Radiology
Akesis Galaxy RTx
FDA 510(k)
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 |
| 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 |
| K820782 | THERATRONIC STIMULATOR | Jun 3, 1982 | Substantially Equivalent |