# K964124: Philips Computed Radiography

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems, Inc.
- Decided: Dec 18, 1996 after 64 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K915237 (1992). 2 ancestors in all.
18 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915237: Philips PCR-Ace System, Philips Medical Systems, Inc. (1992) Summary page 2.
- K951373: Fuji Computed Radiography System FCR9000HQ, FCR9501HQ, Fujifilm Medical System U.S.A., Inc. (1995) Summary page 1.

## Most influential descendants
- K063781: Philips XD-S Direct Radiography Workstation/Package (2007), 16 descendants of its own
- K140771: Philips Eleva Workspot (2014), 15 descendants of its own
- K141736: Philips Prograde; Philips Eleva Workspot for Digital Diagnost (2014), 6 descendants of its own
- K203188: ADD (2021), 3 descendants of its own
- K182973: DigitalDiagnost C90 (2019), 3 descendants of its own

## Recalls of this device
- Aug 12, 2016 · Class II · Z-2681-2016: A defect component of the Compano reader power supply can cause the power supply to burn and some smoke to leave the housing.
- Jul 27, 2011 · Not classified · Z-3205-2011: The mirror icon on the bottom of each image could be interpreted as a RIGHT marker for side indication if the image is mirrored again within a PACS system. This could potentially lead to a misdiagnosi
- Dec 23, 2008 · Not classified · Z-1019-2011: There is a risk of selecting the wrong patient, when patient is selected in the patient list and the examination tab pressed with background query are running at the same time.

## Indications for use
The PCR 5.2 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 Philips PCR 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/K964124
Methodology: https://510kreport.com/methodology