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FDA 510(k)

HISPEED X/I SMART GANTRY OPTION

K-Number: K012385 · 2001-08-10

ApplicantGe Medical Systems, Inc.
Decision Date2001-08-10
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HISPEED X/I SMART GANTRY OPTION is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems, Inc.. It received FDA 510(k) clearance on 2001-08-10 under 510(k) number K012385. 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 HISPEED X/I SMART GANTRY OPTION?

HISPEED X/I SMART GANTRY OPTION is a medical device that received FDA 510(k) clearance on 2001-08-10. The listed applicant is Ge Medical Systems, Inc.. The 510(k) number is K012385.

When did HISPEED X/I SMART GANTRY OPTION receive FDA 510(k) clearance?

HISPEED X/I SMART GANTRY OPTION received FDA 510(k) clearance on 2001-08-10, under 510(k) number K012385.

Who is the listed applicant for HISPEED X/I SMART GANTRY OPTION?

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

What is the FDA product code for HISPEED X/I SMART GANTRY OPTION?

The FDA product code for HISPEED X/I SMART GANTRY OPTION is JAK.

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Other records listing Ge Medical Systems, Inc. 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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