FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
E.CAM LSO 311 PET/SPECT SYSTEM
K Number: K981027
·
Decision Jun 8, 1998
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
459
Applicant Total
19
Review Days
81
Basic Information
- Device Name
- E.CAM LSO 311 PET/SPECT SYSTEM
- K Number
- K981027
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1200
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CTI PET SYSTEMS, INC.
- Date Received
- March 19, 1998
- Decision Date
- June 8, 1998
- 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 |
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Other Clearances by CTI PET SYSTEMS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K050509 | LSO PET/CT HIREZ SERIES, MODELS 2I, 6I, 16I, 64I | Mar 25, 2005 | Substantially Equivalent |
| K042467 | LSO PET/CT HIREZ 64 | Oct 1, 2004 | Substantially Equivalent |
| K040933 | ECAT HRRT | Jun 7, 2004 | Substantially Equivalent |
| K033431 | LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ | Nov 20, 2003 | Substantially Equivalent |
| K023768 | ECAT PET/CT; ECAT LSO PET/CT; ECAT LSO PET/CT 16 | Nov 25, 2002 | Substantially Equivalent |
| K023518 | ECAT LSO PET/CT 16 | Nov 8, 2002 | Substantially Equivalent |
| K021633 | ECAT VISION PET SCANNER, MODELS 3000 & 5000 | Aug 14, 2002 | Substantially Equivalent |
| K013504 | MODIFICATION TO: ECAT LSO PET/CT SCANNER | Oct 31, 2001 | Substantially Equivalent |
| K003241 | ECAT PET SCANNER | Dec 13, 2000 | Substantially Equivalent |
| K002584 | ECAT ACCEL PET SCANNER | Nov 16, 2000 | Substantially Equivalent |