510(k) K242818— IsoSphere

Substantially Equivalent

Isoaid, LLC

Clearance details

Applicant: Isoaid, LLC
Product code: Code KXK
Advisory panel: Radiology
Date received: 2024-09-18
Decision date: 2025-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Port Richey, FL, US

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