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FDA 510(k)

SIGNA™ Bolt

K-Number: K253780 · 2026-02-06

ApplicantGe Medical Systems, LLC
Decision Date2026-02-06
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SIGNA™ Bolt is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2026-02-06 under 510(k) number K253780. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIGNA™ Bolt?

SIGNA™ Bolt is a medical device that received FDA 510(k) clearance on 2026-02-06. The listed applicant is Ge Medical Systems, LLC. The 510(k) number is K253780.

When did SIGNA™ Bolt receive FDA 510(k) clearance?

SIGNA™ Bolt received FDA 510(k) clearance on 2026-02-06, under 510(k) number K253780.

Who is the listed applicant for SIGNA™ Bolt?

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

What is the FDA product code for SIGNA™ Bolt?

The FDA product code for SIGNA™ Bolt is LNH.

Other records listing Ge Medical Systems, LLC 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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Related Devices (Code: LNH)

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.

K253808AIR Recon DLGE Medical SystemsK261331I-Genius (100019400)Esaote, S.p.A.K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AGK260113uMR AstraShanghai United Imaging Healthcare Co., Ltd.K253862APERTO Lucent MRI SystemFujifilm CorporationK260746S-scan Open (100001800)Esaote, S.p.A.

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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