510(k) Report

FDA applicant

Acuson Computed Sonography

Mountain View, CA24 decisions1985–19900 recalls

FDA records 24 decisions for Acuson Computed Sonography (Mountain View, CA) from 1985 to 1990: 24 510(k) clearances. Most are in product codes ITX (Transducer, Ultrasonic, Diagnostic) and JOP (Transducer, Ultrasonic). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Acuson Computed Sonography’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Acuson Computed Sonography since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Acuson Computed Sonography by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Acuson Computed Sonography’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Acuson”

FDA records each applicant name separately; these may or may not be the same firm.