DDRCOMPACT, DDRCOMPACT PLUS AND DDRCOMPACT CHEST— 510(k) K070678

Substantially Equivalent

Swissray International, Inc.

FDA 510(k) clearance K070678 for DDRCOMPACT, DDRCOMPACT PLUS AND DDRCOMPACT CHEST, Substantially Equivalent on 2007-05-02. Applicant: Swissray International, Inc..

Clearance details

Applicant: Swissray International, Inc.
Product code: Code KPR
Advisory panel: Radiology
Date received: 2007-03-12
Decision date: 2007-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elizabeth, NJ, US

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Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

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.