510(k) K182079 ยท IYE Accelerator, Linear, Medical
Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask
| Applicant | Medtec Inc. Dba Civco Medical Solutions, Orange City IA, US |
| Decision | Substantially Equivalent, Sep 7, 2018 |
| Received | Aug 2, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182079
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 15, 2019 | Med Tec Inc CIVCO Solstice(TM) SRS Immobilization System, Part Numbers: a) CHS03, b) CHS04 - Product Usage: The Tilting Head Fixation (Solstice) device is comprised of a baseplate and bowl with a locking lever. Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.