Image Management V15— 510(k) K240822

Substantially Equivalent

Philips Medical Systems Technologies

FDA 510(k) clearance K240822 for Image Management V15, Substantially Equivalent on 2024-04-24. Applicant: Philips Medical Systems Technologies. Device class: 2.

Clearance details

Applicant
Philips Medical Systems Technologies
Product code
Code LLZ
Device class
Class 2
Regulation
21 CFR 892.2050
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Raanana Central, IL
Download summary PDFView on FDA.gov ↗

Recent devices under product code LLZ

view all

Adverse events under product code LLZ

product code LLZ
Death
13
Total
13

Source: openFDA MAUDE database, through . 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.