IMASIGHT 4600 DIGITAL RADIOGRAPHY SENSOR— 510(k) K092307

Substantially Equivalent

Imasight, Inc.

FDA 510(k) clearance K092307 for IMASIGHT 4600 DIGITAL RADIOGRAPHY SENSOR, Substantially Equivalent on 2009-08-25. Applicant: Imasight, Inc..

Clearance details

Applicant: Imasight, Inc.
Product code: Code KPR
Advisory panel: Radiology
Date received: 2009-07-30
Decision date: 2009-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gatineau, Quebec, CA

Download summary PDF View on FDA.gov ↗

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.