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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 the device name listed in this FDA 510(k) record. The listed applicant is Elekta Solutions AB. It received FDA 510(k) clearance on 2020-12-18 under 510(k) 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. The listed applicant is Elekta Solutions AB. The 510(k) number is K203172.

When did MOSAIQ Oncology Information System receive FDA 510(k) clearance?

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

Who is the listed applicant for MOSAIQ Oncology Information System?

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

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

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

Other records listing Elekta Solutions AB as applicant

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Related Devices (Code: IYE)

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.

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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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