DeviceClearance

Enhanced Boundary for PCCT— 510(k) K253560

Substantially Equivalent

Ge Medical Systems, LLC

FDA 510(k) clearance K253560 for Enhanced Boundary for PCCT, Substantially Equivalent on 2026-06-24. Applicant: Ge Medical Systems, LLC. Device class: 2.

Summary

Enhanced Boundary for PCCT comes from GE Medical Systems and is filed under JAK, computed tomography x-ray systems. The record doesn't expand "PCCT" or describe what the product does.

Class II, 21 CFR 892.1750. Radiology is both the classification panel and the review panel. It came in as a Traditional 510(k).

GE filed from Waukesha, Wisconsin. The decision came 219 calendar days after FDA received it (November 17, 2025 to June 24, 2026).

Clearance details

Applicant
Ge Medical Systems, LLC
Product code
Product code JAK
Device class
Class 2
Regulation
21 CFR 892.1750
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Waukesha, WI, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code JAK

product code JAK
Death
27
Injury
571
Malfunction
779
Total
1,377

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.