FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask
K Number: K182079
·
Decision Sep 7, 2018
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
2
Review Days
36
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Basic Information
- Device Name
- Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask
- K Number
- K182079
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtec Inc. Dba Civco Medical Solutions
- Date Received
- August 2, 2018
- Decision Date
- September 7, 2018
- Product Code
- IYE
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
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 Medtec Inc. Dba Civco Medical Solutions
| K Number | Device Name | ||
|---|---|---|---|
| K121545 | BELLYBOARD, SBRT ACCESSORIES | Jun 8, 2012 | Substantially Equivalent |