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FDA 510(k)

MOSAIQ® OIS (Oncology Information System)

K-Number: K223229 · 2023-02-23

ApplicantElekta Solutions AB
Decision Date2023-02-23
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MOSAIQ® OIS (Oncology Information System) is a medical device manufactured by Elekta Solutions AB. It received FDA 510(k) clearance on 2023-02-23 under approval number K223229. 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® OIS (Oncology Information System)?

MOSAIQ® OIS (Oncology Information System) is a medical device that received FDA 510(k) clearance on 2023-02-23. It is manufactured by Elekta Solutions AB. The 510(k) number is K223229.

When was MOSAIQ® OIS (Oncology Information System) approved by the FDA?

MOSAIQ® OIS (Oncology Information System) received FDA 510(k) clearance on 2023-02-23, under approval number K223229.

What company makes MOSAIQ® OIS (Oncology Information System)?

MOSAIQ® OIS (Oncology Information System) is manufactured by Elekta Solutions AB.

What is the FDA product code for MOSAIQ® OIS (Oncology Information System)?

The FDA product code for MOSAIQ® OIS (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)

Other Devices by Elekta Solutions AB

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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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