# K093355: PCR Eleva 1.2

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems, Inc.
- Decided: Jan 8, 2010 after 73 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: 2 generations back to K915237 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964124: Philips Computed Radiography, Philips Medical Systems, Inc. (1996) Summary page 2.

## Indications for use
The PCR Eleva System is a digital film processing system for reading and then digitizing X-ray images from reusable imaging plates which have been exposed in conventional radiographic examination devices. The digitized X-ray images can then be viewed, stored, post-processed and printed. The PCR Eleva system can be used in all conventional RAD/RF examination situations, except for mammography. PCR is suitable for routine RAD exams as well as specialist areas, like intensive care units, trauma departments and pediatric departments.

Source page: https://510kreport.com/device/K093355
Methodology: https://510kreport.com/methodology