FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COMPUTE-RX-COMP (TM)
K Number: K910367
·
Decision May 30, 1991
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
69
Applicant Total
2
Review Days
121
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Basic Information
- Device Name
- COMPUTE-RX-COMP (TM)
- K Number
- K910367
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5840
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Medicalibration Physics Consultant Services, Inc.
- Date Received
- January 29, 1991
- Decision Date
- May 30, 1991
- Product Code
- KPQ
- 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 |
|---|---|---|---|
| KPQ | System, Simulation, Radiation Therapy | FDA class 2 | Radiology |
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Other Clearances by Medicalibration Physics Consultant Services, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K953508 | COMPUTE-RX PLAN PC3D | Feb 26, 1996 | Substantially Equivalent |