# K023440: Philips Digital Imaging Option Release 1

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems
- Decided: Oct 30, 2002 after 15 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K920793 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920793: Philips Dsi System Release 3.2, Philips Medical Systems, Inc. (1992) Summary page 1.

## Recalls of this device
- Jan 4, 2008 · Not classified · Z-2406-2010: Potential for the tower (holding the serial changer and/or image intensifier) to slide unexpectedly and potentially injure a patient or user in its path.

## Indications for use
The Digital Imaging option release 1 is intended to assist physicians for diagnostic purposes and is required for interventional procedures, providing digital functionality as Last Image Hold, Digital Subtraction and contains a user interface for viewing, reviewing and processing digital images. The Digital Imaging option release 1 includes the following features, such as : 1. Providing Digital Acquisition or Fluoroscopy for Philips RF systems. 2. Diagnostic andor lnterventionalapplications. 3. Live subtracted acquisition and fluoroscopy for vascular applications. 4. Single or multiple images can be acquired and reviewed. 5. Sending digital images to printer, external workstations for post processing and reconstructions, PACS.

Source page: https://510kreport.com/device/K023440
Methodology: https://510kreport.com/methodology