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FDA 510(k)

SCX SYSTEM

K-Number: K862120 · 1986-06-16

ApplicantGeneral Electric Co.
Decision Date1986-06-16
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SCX SYSTEM 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 1986-06-16 under 510(k) number K862120. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCX SYSTEM?

SCX SYSTEM is a medical device that received FDA 510(k) clearance on 1986-06-16. The listed applicant is General Electric Co.. The 510(k) number is K862120.

When did SCX SYSTEM receive FDA 510(k) clearance?

SCX SYSTEM received FDA 510(k) clearance on 1986-06-16, under 510(k) number K862120.

Who is the listed applicant for SCX SYSTEM?

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 SCX SYSTEM?

The FDA product code for SCX SYSTEM is JAA.

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Related Devices (Code: JAA)

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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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