FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
APOLLO GAMMA CAMERA SYSTEM
K Number: K062298
·
Decision Aug 23, 2006
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
470
Applicant Total
88
Review Days
15
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Basic Information
- Device Name
- APOLLO GAMMA CAMERA SYSTEM
- K Number
- K062298
- 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
- August 8, 2006
- Decision Date
- August 23, 2006
- Product Code
- KPS
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
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 Adac Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K040142 | ENSPHERE TEMPO JETSTREAM WORKSPACE CARDIOLOGY MODULE | Feb 6, 2004 | Substantially Equivalent |