FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TECNOTOMO
K Number: K790132
·
Decision Feb 21, 1979
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
41
Applicant Total
7
Review Days
29
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
- TECNOTOMO
- K Number
- K790132
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1740
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Teknomed, Inc.
- Date Received
- January 23, 1979
- Decision Date
- February 21, 1979
- Product Code
- IZF
- 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 |
|---|---|---|---|
| IZF | System, X-Ray, Tomographic | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IZF), ordered by most recent decision date.
TAP2D
FDA 510(k)
FDA Class 2
·Radiology
Adaptix Ortho350
FDA 510(k)
FDA Class 2
·Radiology
Nanox.ARC X
FDA 510(k)
FDA Class 2
·Radiology
Nanox.ARC
FDA 510(k)
FDA Class 2
·Radiology
Nanox.ARC
FDA 510(k)
FDA Class 2
·Radiology
Ortho Device, ADAPTIX 3D Orthopedic Imaging System
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Teknomed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K925395 | TECHNOMED PULSOLITH 4000 LASER SYSTEM | May 21, 1993 | Substantially Equivalent |
| K920708 | MULTILASE 2500 A | Nov 5, 1992 | Substantially Equivalent |
| K913917 | MULTILASE 2100 C, 2100 D | Nov 5, 1992 | Substantially Equivalent |
| K913290 | MULTILASE 2100 A | Feb 21, 1992 | Substantially Equivalent |
| K895178 | TECHNOMED PULSOLITH LASER SYSTEM | Oct 6, 1989 | Substantially Equivalent |
| K890436 | TECHNOMED PULSOLITH LASER SYSTEM | Mar 23, 1989 | Substantially Equivalent |