510(k) K182079
K182079 is an FDA 510(k) premarket notification submitted by Medtec Inc. Dba Civco Medical Solutions for the device "Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask". The FDA issued a decision of Substantially Equivalent on Sep 7, 2018. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Medtec Inc. Dba Civco Medical Solutions has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 7, 2018
- Date Received
- Aug 2, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Accelerator, Linear, Medical
- Device Class
- Class II
- Regulation Number
- 892.5050
- Review Panel
- RA
- Submission Type
- 510(k)