# K980918: JPACS

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Jun 3, 1998 after 84 days
- Product code: LMD (System, Digital Image Communications, Radiological)
- Device class: 1
- Regulation: 21 CFR 892.2020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K954678 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971347: Medisurf, International Regulatory Consultants (1997) Summary page 1.

## Indications for use
The JPACS radiology suite provides access to clinical reports and images via computer networks. Given the following information objects, the JPACS radiology suite may be used on any part of the human anatomy: CR, CT, MR, XA, SC, US, NM, PET, and RT. The suite also provides short, medium, and long term storage of these clinical images from any authorized workstation within an intranet or over the Internet. The full feature imaging suite can be used for in-house image distribution, on-call teleradiology, and advance visual display features. The JPACS radiology suite also includes functionality for generation and distribution of clinical reports.

Source page: https://510kreport.com/device/K980918
Methodology: https://510kreport.com/methodology