FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODEL DVS-I-11: DVS INSERTION TOOL, DVS-D-A: DVS DOSIMETER, DVS-R-100
K Number: K071399
·
Decision Jun 20, 2007
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
91
Applicant Total
7
Review Days
30
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Basic Information
- Device Name
- DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODEL DVS-I-11: DVS INSERTION TOOL, DVS-D-A: DVS DOSIMETER, DVS-R-100
- K Number
- K071399
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sicel Technologies, Inc.
- Date Received
- May 21, 2007
- Decision Date
- June 20, 2007
- Product Code
- LHN
- 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 |
|---|---|---|---|
| LHN | System, Radiation Therapy, Charged-Particle, Medical | FDA class 2 | Radiology |
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Other Clearances by Sicel Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K083035 | DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM | Nov 13, 2008 | Substantially Equivalent |
| K081859 | MODIFICATION TO ONEDOSE PATIENT DOSIMETRY SYSTEM | Aug 4, 2008 | Substantially Equivalent |
| K080004 | DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM | Jan 23, 2008 | Substantially Equivalent |
| K061051 | DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODELS DVS-I-11, DVS INSERTION TOOL, DVS-D-A, DVS DOSIMETER | Jun 13, 2006 | Substantially Equivalent |
| K052118 | DOSE VERIFICATION SYSTEM | Apr 3, 2006 | Substantially Equivalent |
| K040687 | ONEDOSE PATIENT DOSIMETRY SYSTEM | Jun 25, 2004 | Substantially Equivalent |