FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION
K Number: K132944
·
Decision Mar 14, 2014
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
69
Applicant Total
2
Review Days
176
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Basic Information
- Device Name
- ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION
- K Number
- K132944
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5840
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ge Hungary Kft
- Date Received
- September 19, 2013
- Decision Date
- March 14, 2014
- Product Code
- KPQ
- 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 |
|---|---|---|---|
| KPQ | System, Simulation, Radiation Therapy | FDA class 2 | Radiology |
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Other Clearances by Ge Hungary Kft
| K Number | Device Name | ||
|---|---|---|---|
| K132045 | ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS | Sep 4, 2013 | Substantially Equivalent |