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FDA 510(k)

SATURNE MULTILEAF COLLIMATOR

K-Number: K970303 · 1997-04-25

ApplicantGeneral Electric Co.
Decision Date1997-04-25
Product CodeIXI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SATURNE MULTILEAF COLLIMATOR is the device name listed in this FDA 510(k) record. The listed applicant is General Electric Co.. It received FDA 510(k) clearance on 1997-04-25 under 510(k) number K970303. The device is classified under product code IXI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SATURNE MULTILEAF COLLIMATOR?

SATURNE MULTILEAF COLLIMATOR is a medical device that received FDA 510(k) clearance on 1997-04-25. The listed applicant is General Electric Co.. The 510(k) number is K970303.

When did SATURNE MULTILEAF COLLIMATOR receive FDA 510(k) clearance?

SATURNE MULTILEAF COLLIMATOR received FDA 510(k) clearance on 1997-04-25, under 510(k) number K970303.

Who is the listed applicant for SATURNE MULTILEAF COLLIMATOR?

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

What is the FDA product code for SATURNE MULTILEAF COLLIMATOR?

The FDA product code for SATURNE MULTILEAF COLLIMATOR is IXI.

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Other records listing General Electric Co. as applicant

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Related Devices (Code: IXI)

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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