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)

SOFTDISO

K-Number: K170345 · 2017-10-27

ApplicantBest Nomos
Decision Date2017-10-27
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SOFTDISO is a medical device manufactured by Best Nomos. It received FDA 510(k) clearance on 2017-10-27 under approval number K170345. 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 SOFTDISO?

SOFTDISO is a medical device that received FDA 510(k) clearance on 2017-10-27. It is manufactured by Best Nomos. The 510(k) number is K170345.

When was SOFTDISO approved by the FDA?

SOFTDISO received FDA 510(k) clearance on 2017-10-27, under approval number K170345.

What company makes SOFTDISO?

SOFTDISO is manufactured by Best Nomos.

What is the FDA product code for SOFTDISO?

The FDA product code for SOFTDISO is IYE.

Other Devices by Best Nomos

K201350CORVUS K211034Corvus Radiation Therapy Planning System

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.

↑