FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Z XT RADIATION THERAPY TREATMENT TABLE
K Number: K910971
·
Decision May 3, 1991
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
31
Applicant Total
13
Review Days
57
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
- Z XT RADIATION THERAPY TREATMENT TABLE
- K Number
- K910971
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5770
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Siemens Medical Laboratories, Inc.
- Date Received
- March 7, 1991
- Decision Date
- May 3, 1991
- Product Code
- JAI
- 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 |
|---|---|---|---|
| JAI | Couch, Radiation Therapy, Powered | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JAI), ordered by most recent decision date.
Eve Patient Positioner System
FDA 510(k)
FDA Class 2
·Radiology
Z-Robot Patient Positioning System
FDA 510(k)
FDA Class 2
·Radiology
Patient Positioning System
FDA 510(k)
FDA Class 2
·Radiology
LEONI ORION System
FDA 510(k)
FDA Class 2
·Radiology
PROTURA COUCH SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
PATIENT POSITIONING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Siemens Medical Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K903139 | BEAMVIEW & BEAMVIEW PLUS (AKA PROJECT 743) | Nov 7, 1990 | Substantially Equivalent |
| K894230 | PATIENT DATA MANAGEMENT SYSTEM (PROJECT 735) | Aug 28, 1989 | Substantially Equivalent |
| K882729 | MEVATRON, M 2 CLASS | Sep 19, 1988 | Substantially Equivalent |
| K875272 | SONOLINE CF | Feb 18, 1988 | Substantially Equivalent |
| K862339 | MEVATRON KD-2 | Oct 29, 1986 | Substantially Equivalent |
| K854609 | MEVAMATIC 3 | Feb 21, 1986 | Substantially Equivalent |
| K852907 | SIEMENS MEVATRON ME | Sep 19, 1985 | Substantially Equivalent |
| K812032 | MEVATRON 67E | Aug 18, 1981 | Substantially Equivalent |
| K791967 | MEVATRON 74X MEDICAL LINEAR ACCELERATOR | Nov 16, 1979 | Substantially Equivalent |
| K790747 | MEVATRON 74 | May 4, 1979 | Substantially Equivalent |