FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DIGITAL PROCESSING SYSTEM
K Number: K840052
·
Decision Mar 22, 1984
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
129
Applicant Total
88
Review Days
76
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Basic Information
- Device Name
- DIGITAL PROCESSING SYSTEM
- K Number
- K840052
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1100
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Adac Laboratories
- Date Received
- January 6, 1984
- Decision Date
- March 22, 1984
- 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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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 |