FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROTEC (1024)
K Number: K963730
·
Decision Feb 10, 1997
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
459
Applicant Total
1
Review Days
147
Basic Information
- Device Name
- PROTEC (1024)
- K Number
- K963730
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1200
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- PROPORTIONAL TECHNOLOGIES, INC.
- Date Received
- September 16, 1996
- Decision Date
- February 10, 1997
- Product Code
- KPS
- 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 |
|---|---|---|---|
| KPS | System, Tomography, Computed, Emission | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KPS), ordered by most recent decision date.
Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems
FDA 510(k)
FDA Class 2
·Radiology
Aurora
FDA 510(k)
FDA Class 2
·Radiology
HeartSee Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4
FDA 510(k)
FDA Class 2
·Radiology
Imaging system of positron emission and X-ray computed tomography (DigitMI 930)
FDA 510(k)
FDA Class 2
·Radiology
Aurora
FDA 510(k)
FDA Class 2
·Radiology
uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)
FDA 510(k)
FDA Class 2
·Radiology