MAXXUS— 510(k) K924498

Substantially Equivalent

GE Medical Systems

FDA 510(k) clearance K924498 for MAXXUS, Substantially Equivalent on 1992-12-03. Applicant: GE Medical Systems. Device class: 2.

Clearance details

Applicant: GE Medical Systems
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 1992-09-04
Decision date: 1992-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milwaukee, WI, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K924498

K-number listed on FDA's recall record

Z-1047-2026 — MAXXUS, System, Tomography, Computed, EmissionClass II·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·20251210

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K924498.

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