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FDA 510(k)

Synergy Platform, Synergy, Infinity, VersaHD

K-Number: K192242 · 2019-11-22

ApplicantElekta Limited
Decision Date2019-11-22
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Synergy Platform, Synergy, Infinity, VersaHD is the device name listed in this FDA 510(k) record. The listed applicant is Elekta Limited. It received FDA 510(k) clearance on 2019-11-22 under 510(k) number K192242. 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 Synergy Platform, Synergy, Infinity, VersaHD?

Synergy Platform, Synergy, Infinity, VersaHD is a medical device that received FDA 510(k) clearance on 2019-11-22. The listed applicant is Elekta Limited. The 510(k) number is K192242.

When did Synergy Platform, Synergy, Infinity, VersaHD receive FDA 510(k) clearance?

Synergy Platform, Synergy, Infinity, VersaHD received FDA 510(k) clearance on 2019-11-22, under 510(k) number K192242.

Who is the listed applicant for Synergy Platform, Synergy, Infinity, VersaHD?

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

What is the FDA product code for Synergy Platform, Synergy, Infinity, VersaHD?

The FDA product code for Synergy Platform, Synergy, Infinity, VersaHD is IYE.

Other records listing Elekta Limited 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.

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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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