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FDA 510(k)

MOSAIQ Oncology Information System

K-Number: K183034 · 2018-12-04

ApplicantElekta, Inc.
Decision Date2018-12-04
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MOSAIQ Oncology Information System is a medical device manufactured by Elekta, Inc.. It received FDA 510(k) clearance on 2018-12-04 under approval number K183034. 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 MOSAIQ Oncology Information System?

MOSAIQ Oncology Information System is a medical device that received FDA 510(k) clearance on 2018-12-04. It is manufactured by Elekta, Inc.. The 510(k) number is K183034.

When was MOSAIQ Oncology Information System approved by the FDA?

MOSAIQ Oncology Information System received FDA 510(k) clearance on 2018-12-04, under approval number K183034.

What company makes MOSAIQ Oncology Information System?

MOSAIQ Oncology Information System is manufactured by Elekta, Inc..

What is the FDA product code for MOSAIQ Oncology Information System?

The FDA product code for MOSAIQ Oncology Information System is IYE.

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Related PubMed Literature

PMID: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025)

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Official Source

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

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