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FDA 510(k)

ELEKTA SYNERGY SYSTEM

K-Number: K032996 · 2003-10-23

ApplicantElekta Oncology Systems, Ltd.
Decision Date2003-10-23
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ELEKTA SYNERGY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Elekta Oncology Systems, Ltd.. It received FDA 510(k) clearance on 2003-10-23 under 510(k) number K032996. 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 ELEKTA SYNERGY SYSTEM?

ELEKTA SYNERGY SYSTEM is a medical device that received FDA 510(k) clearance on 2003-10-23. The listed applicant is Elekta Oncology Systems, Ltd.. The 510(k) number is K032996.

When did ELEKTA SYNERGY SYSTEM receive FDA 510(k) clearance?

ELEKTA SYNERGY SYSTEM received FDA 510(k) clearance on 2003-10-23, under 510(k) number K032996.

Who is the listed applicant for ELEKTA SYNERGY SYSTEM?

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

What is the FDA product code for ELEKTA SYNERGY SYSTEM?

The FDA product code for ELEKTA SYNERGY SYSTEM is IYE.

Related Clinical Trials

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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Other records listing Elekta Oncology Systems, Ltd. 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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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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