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FDA 510(k)

LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEM

K-Number: K030420 · 2003-03-10

ApplicantGE Medical Systems
Decision Date2003-03-10
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems. It received FDA 510(k) clearance on 2003-03-10 under 510(k) number K030420. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEM?

LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEM is a medical device that received FDA 510(k) clearance on 2003-03-10. The listed applicant is GE Medical Systems. The 510(k) number is K030420.

When did LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEM receive FDA 510(k) clearance?

LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEM received FDA 510(k) clearance on 2003-03-10, under 510(k) number K030420.

Who is the listed applicant for LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEM?

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

What is the FDA product code for LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEM?

The FDA product code for LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEM is JAK.

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Other records listing GE Medical Systems as applicant

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Related Devices (Code: JAK)

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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