FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INSPECT/PROSPECT
K Number: K952564
·
Decision Nov 22, 1995
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
459
Applicant Total
88
Review Days
173
Basic Information
- Device Name
- INSPECT/PROSPECT
- K Number
- K952564
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1200
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ADAC LABORATORIES
- Date Received
- June 2, 1995
- Decision Date
- November 22, 1995
- 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
Other Clearances by ADAC LABORATORIES
| K Number | Device Name | ||
|---|---|---|---|
| K062298 | APOLLO GAMMA CAMERA SYSTEM | Aug 23, 2006 | Substantially Equivalent |
| K061029 | JETSTREAM WORKSPACE | May 1, 2006 | Substantially Equivalent |
| K060020 | AUTOQUANT PLUS | Jan 20, 2006 | Substantially Equivalent |
| K051351 | PRECEDENCE SPECT/CT IMAGING SYSTEM | Jun 8, 2005 | Substantially Equivalent |
| K042880 | JETSTREAM WORKSPACE | Nov 3, 2004 | Substantially Equivalent |
| K042903 | AUTOSPECS | Oct 29, 2004 | Substantially Equivalent |
| K041577 | PINNACLE3 RADIATION THERAPY PLANNING SYSTEM | Jun 25, 2004 | Substantially Equivalent |
| K041218 | GRIFFIN SPECT/CT IMAGING SYSTEM | May 24, 2004 | Substantially Equivalent |
| K041182 | SYNTEGRA | May 21, 2004 | Substantially Equivalent |
| K040326 | AUTOQUANT PLUS | Feb 25, 2004 | Substantially Equivalent |