FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROTURA COUCH SOFTWARE
K Number: K132084
·
Decision Sep 26, 2013
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
31
Applicant Total
2
Review Days
83
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Basic Information
- Device Name
- PROTURA COUCH SOFTWARE
- K Number
- K132084
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5770
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Med-Tec, Inc. D/B/A Civco Medical Solutions
- Date Received
- July 5, 2013
- Decision Date
- September 26, 2013
- Product Code
- JAI
- 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 |
|---|---|---|---|
| JAI | Couch, Radiation Therapy, Powered | FDA class 2 | Radiology |
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Other Clearances by Med-Tec, Inc. D/B/A Civco Medical Solutions
| K Number | Device Name | ||
|---|---|---|---|
| K122201 | PROTURA COUCH SOFTWARE | Aug 30, 2012 | Substantially Equivalent |