FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STANDARD IMAGING IMSURE BRACHY QA SOFTWARE, MODEL 91331
K Number: K082773
·
Decision Nov 19, 2008
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
10
Review Days
58
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Basic Information
- Device Name
- STANDARD IMAGING IMSURE BRACHY QA SOFTWARE, MODEL 91331
- K Number
- K082773
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Standard Imaging, Inc.
- Date Received
- September 22, 2008
- Decision Date
- November 19, 2008
- Product Code
- IYE
- 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 |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | FDA class 2 | Radiology |
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Other Clearances by Standard Imaging, Inc.
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|---|---|---|---|
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| K040688 | STANDARD IMAGING E.IMRT CALCULATOR | May 11, 2004 | Substantially Equivalent |
| K013548 | STANDARD IMAGING IVB 1000 WELL CHAMBER | Nov 9, 2001 | Substantially Equivalent |
| K002833 | MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER | Sep 28, 2000 | Substantially Equivalent |
| K001825 | STANDARD IMAGING HDR 1000 PLUS ION CHAMBER; STANDARD IMAGING IVB 1000 ION CHAMBER | Aug 2, 2000 | Substantially Equivalent |
| K940539 | STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM | Mar 16, 1994 | Substantially Equivalent |
| K922554 | STANDARD IMAGING HDR 1000 ION CHAMBER | Aug 24, 1992 | Substantially Equivalent |