FDA 510(k)
FDA class 1
Substantially Equivalent
🇩🇰 Denmark
ADAC S315
K Number: K921296
·
Decision May 28, 1992
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
129
Applicant Total
88
Review Days
72
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Basic Information
- Device Name
- ADAC S315
- K Number
- K921296
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1100
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Adac Laboratories
- Date Received
- March 17, 1992
- Decision Date
- May 28, 1992
- Product Code
- IYX
- 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 |
|---|---|---|---|
| IYX | Camera, Scintillation (Gamma) | FDA class 1 | Radiology |
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| 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 |