DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 D— 510(k) K042361

Substantially Equivalent

Sedecal USA, Inc.

FDA 510(k) clearance K042361 for DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 D, Substantially Equivalent on 2004-09-29. Applicant: Sedecal USA, Inc..

Clearance details

Applicant: Sedecal USA, Inc.
Product code: Code IZL
Advisory panel: Radiology
Date received: 2004-08-31
Decision date: 2004-09-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Deer Field, IL, US

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Adverse events under product code IZL

product code IZL

Other: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.