SYNERAD IMPACT 60, SYNERAD IMPACT 72 AND ANALOGIC AMS1600— 510(k) K052447

Substantially Equivalent

Analogic Corp.

FDA 510(k) clearance K052447 for SYNERAD IMPACT 60, SYNERAD IMPACT 72 AND ANALOGIC AMS1600, Substantially Equivalent on 2005-09-21. Applicant: Analogic Corp..

Clearance details

Applicant: Analogic Corp.
Product code: Code JAK
Advisory panel: Radiology
Date received: 2005-09-07
Decision date: 2005-09-21
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Peabody, MA, US

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Adverse events under product code JAK

product code JAK

Death: 27
Injury: 571
Malfunction: 779
Total: 1,377

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.