# K240822: Image Management V15

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems Technologies
- Decided: Apr 24, 2024 after 30 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K954678 (1996). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110919: Carestream Pacs, Carestream Health, Inc. (2011) Summary page 5.

## Indications for use
Image Management is intended to provide complete and scalable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve, process and display medical images and data from hospital medical imaging and information systems. The device contains clinical applications that assist the processing, analyzing and comparing of medical images. It is a single device that integrates the review, dictation and reporting tools to create a productive work environment for the radiologists and physicians. The Image Management viewers are used for patient exam management by clinicians in order to access and display patient data, medical reports, medical data and medical images from different modalities including but not limited to CR, DR, CT, MR, NM, ECG, US, MG*, DBT*, OP and OPT. The device provides wireless and portable access to medical images for remote reading or referral purposes from web browsers using current standard HTML. *For primary interpretation and review of mammography images, only use display hardware that is specifically designed for and cleared by FDA for mammography.

Source page: https://510kreport.com/device/K240822
Methodology: https://510kreport.com/methodology