FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RTP-5100-5200-5300 & 5400
K Number: K833560
·
Decision Dec 8, 1983
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
52
Applicant Total
88
Review Days
51
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Basic Information
- Device Name
- RTP-5100-5200-5300 & 5400
- K Number
- K833560
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5900
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Adac Laboratories
- Date Received
- October 18, 1983
- Decision Date
- December 8, 1983
- Product Code
- JAD
- 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 |
|---|---|---|---|
| JAD | System, Therapeutic, X-Ray | FDA class 2 | 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 |