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FDA 510(k)

Enhanced Boundary for PCCT

K-Number: K253560 · 2026-06-24

ApplicantGe Medical Systems, LLC
Decision Date2026-06-24
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Enhanced Boundary for PCCT 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 2026-06-24 under 510(k) number K253560. 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 Enhanced Boundary for PCCT?

Enhanced Boundary for PCCT is a medical device that received FDA 510(k) clearance on 2026-06-24. The listed applicant is Ge Medical Systems, LLC. The 510(k) number is K253560.

When did Enhanced Boundary for PCCT receive FDA 510(k) clearance?

Enhanced Boundary for PCCT received FDA 510(k) clearance on 2026-06-24, under 510(k) number K253560.

Who is the listed applicant for Enhanced Boundary for PCCT?

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 Enhanced Boundary for PCCT?

The FDA product code for Enhanced Boundary for PCCT is JAK.

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: 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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