# K031597: Dunlee Format Collimator Family

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems North America Co.
- Decided: Jul 21, 2003 after 61 days
- Product code: IZW (Collimator, Automatic, Radiographic)
- Device class: 2
- Regulation: 21 CFR 892.1610
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K990423 (1999). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990423: Philips Nicol Collimator Family, Philips Medical Systems, Inc. (1999) Summary page 1.
- (no number) Pre-amendment manual collimators with codenumbers 9804 602 60501 and 9804 602 61501 (BRH accession number 7410693), manufactured by Philips Medical Systems: named in the summary without a submission number

## Most influential descendants
- K050092: R605 Facs Collimeter (2005), 4 descendants of its own
- K072780: Model R302DACS/a Automatic X-Ray Collimator (2007), 2 descendants of its own
- K093572: R650 Qdasm Collimator (2010), 0 descendants of its own
- K091517: Ralco, Model R225 Acs (2009), 0 descendants of its own
- K083029: Model R605DASM Automatic X-Ray Collimator (2008), 0 descendants of its own

## Indications for use
The Format collimator family will be used in Radiography, Fluoroscopy, Cardio and Vascular X-ray systems. It has the following functionality (configuration dependant): X-ray field limitation (rectangular, and circular); rectangular shuttering in some configurations with direct user control at the collimator head (direct shutter control) Simulation of X-ray field by a light field Measurement of source image distance (with an electronic or mechanical ruler) Spectral filtering Wedge filtering (semi-transparent filtering) Dose measurement (Area Exposure Product Measurement device) Format family consists of a manual version and automatic versions. The product configuration of the automatic version depends on the configuration of the X-ray system. It's a modular concept in which collimator functionalities can be added for radiographic or fluoroscopy applications. The automatic collimators have an ISO-CAN software interface with the system through which they receive system commands at openclose level.

Source page: https://510kreport.com/device/K031597
Methodology: https://510kreport.com/methodology