Image Management V15

FDA 510(k) K240822 · Philips Medical Systems Technologies

Substantially Equivalent

510(k) numberK240822

Submission

Device name
Image Management V15
Applicant
Philips Medical Systems Technologies
Raanana Central, IL
Received
March 25, 2024
Decision date
April 24, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

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 Image Management V15 cleared by the FDA?

Image Management V15 (K240822) received a 510(k) decision of Substantially Equivalent on April 24, 2024, 30 days after the submission was received.

What is the product code of K240822?

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