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FDA 510(k)

MOSAIQ Oncology Information System

K-Number: K203172 · 2020-12-18

ApplicantElekta Solutions AB
Decision Date2020-12-18
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MOSAIQ Oncology Information System is a medical device manufactured by Elekta Solutions AB. It received FDA 510(k) clearance on 2020-12-18 under approval number K203172. 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 2020-12-18. It is manufactured by Elekta Solutions AB. The 510(k) number is K203172.

When was MOSAIQ Oncology Information System approved by the FDA?

MOSAIQ Oncology Information System received FDA 510(k) clearance on 2020-12-18, under approval number K203172.

What company makes MOSAIQ Oncology Information System?

MOSAIQ Oncology Information System is manufactured by Elekta Solutions AB.

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

View on FDA Database →

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

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