SOPHYCAMERA DSX RECTANGULAR— 510(k) K894931

Name: FDA 510(k) clearance K894931
Creator: U.S. Food and Drug Administration
Published: 1989-10-27

Substantially Equivalent

Sopha Medical Systems, Inc.

FDA 510(k) clearance K894931 for SOPHYCAMERA DSX RECTANGULAR, Substantially Equivalent on 1989-10-27. Applicant: Sopha Medical Systems, Inc.. Device class: 1.

Clearance details

Applicant: Sopha Medical Systems, Inc.
Product code: Code IYX
Device class: Class 1
Regulation: 21 CFR 892.1100
Advisory panel: Radiology
Date received: 1989-08-02
Decision date: 1989-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K894931

K-number listed on FDA's recall record

Z-1044-2026 — SMV DSX New Line, 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 K894931.

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