Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask

K-Number: K182079 · 2018-09-07

ApplicantMedtec Inc. Dba Civco Medical Solutions
Decision Date2018-09-07
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask is a medical device manufactured by Medtec Inc. Dba Civco Medical Solutions. It received FDA 510(k) clearance on 2018-09-07 under approval number K182079. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask?

Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask is a medical device that received FDA 510(k) clearance on 2018-09-07. It is manufactured by Medtec Inc. Dba Civco Medical Solutions. The 510(k) number is K182079.

When was Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask approved by the FDA?

Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask received FDA 510(k) clearance on 2018-09-07, under approval number K182079.

What company makes Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask?

Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask is manufactured by Medtec Inc. Dba Civco Medical Solutions.

What is the FDA product code for Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask?

The FDA product code for Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask is IYE.

Related Clinical Trials

NCT07598604 Early Mobilization and Equinus Correction in Spastic Cerebral Palsy NOT_YET_RECRUITING NCT05489822 PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use. TERMINATED NCT04784832 TMS-based Assessment of Mental Training Effects on Motor Learning in Healthy Participants RECRUITING

Related Devices (Code: IYE)

K162476Varian High Energy Linear AcceleratorVarian Medical Systems, Inc. K161400ImagingRing SystemMedphoton GmbH K162468ClearCheckRadformation K162355Raycast MammoRx Carbon Fibre Breast BoardOrfit Industries NV K162577Dosimetry Check Version 5 Release 1Math Resolutions, LLC K162265CushionCast Moldable CushionsIzi Medical Products, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑