FDA 510(k)

SOFTDISO

K-Number: K170345 · 2017-10-27

Decision Date2017-10-27

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SOFTDISO is the device name listed in this FDA 510(k) record. The listed applicant is Best Nomos. It received FDA 510(k) clearance on 2017-10-27 under 510(k) 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. The listed applicant is Best Nomos. The 510(k) number is K170345.

When did SOFTDISO receive FDA 510(k) clearance?

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

Who is the listed applicant for SOFTDISO?

The FDA 510(k) record lists Best Nomos as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOFTDISO?

The FDA product code for SOFTDISO is IYE.

Other records listing Best Nomos as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K211034Corvus Radiation Therapy Planning System K201350CORVUS

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Official Source

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