RSVP HALF SPHERE PHANTOM, MODEL DDP010— 510(k) K082909

Substantially Equivalent

The Phantom Laboratory, Inc.

FDA 510(k) clearance K082909 for RSVP HALF SPHERE PHANTOM, MODEL DDP010, Substantially Equivalent on 2008-12-23. Applicant: The Phantom Laboratory, Inc..

Clearance details

Applicant: The Phantom Laboratory, Inc.
Product code: Code IYE
Advisory panel: Radiology
Date received: 2008-09-30
Decision date: 2008-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salem, NY, US

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Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

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.