CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEM— 510(k) K081836

Name: FDA 510(k) clearance K081836
Creator: U.S. Food and Drug Administration
Published: 2008-07-30

Substantially Equivalent

Carestream Health, Inc.

FDA 510(k) clearance K081836 for CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEM, Substantially Equivalent on 2008-07-30. Applicant: Carestream Health, Inc.. Device class: 2.

Clearance details

Applicant: Carestream Health, Inc.
Product code: Code KPR
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2008-06-30
Decision date: 2008-07-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Rochester, NY, US

Download summary PDF View on FDA.gov ↗

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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.