AspenView

FDA 510(k) K241425 · Aspen Imaging Healthcare, Inc.

Substantially Equivalent

510(k) numberK241425

Submission

Device name
AspenView
Applicant
Aspen Imaging Healthcare, Inc.
Plano, TX, US
Received
May 20, 2024
Decision date
February 12, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LLZ – System, Image Processing, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

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Questions and answers

When was AspenView cleared by the FDA?

AspenView (K241425) received a 510(k) decision of Substantially Equivalent on February 12, 2025, 268 days after the submission was received.

What is the product code of K241425?

The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.