# K041935: DR Systems Pacs, Release 6.1

- Pathway: 510(k) (Traditional)
- Applicant: Dr Systems, Inc.
- Decided: Aug 16, 2004 after 28 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K913770 (1991). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033400: Seno Advantage, Ge Medical Systems W-400 (2003) Summary page 1.
- K033712: Modification to Sectra IDS5 Radiology Workstation - Version 10.1, Sectra-Imtec AB (2003) Summary page 1.
- K040376: Sectra IDS5 Radiology Workstation; Sectra MPR Package; Sectra 3D Package, Sectra-Imtec AB (2004) Summary page 1.

## Most influential descendants
- K081168: Brit Pacs Systems (2009), 0 descendants of its own

## Recalls of this device
- Aug 14, 2017 · Class II · Z-3105-2017: The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.
- Aug 7, 2017 · Class II · Z-2566-2018: The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.
- Apr 8, 2016 · Class II · Z-1385-2017: The software is not adding the correct tomo image.
- Apr 8, 2016 · Class II · Z-1426-2017: Reports were missing demographic header information when they were faxed to referring physicians.
- Oct 15, 2015 · Class II · Z-0939-2017: The software fails to associate to the correct MG image if there are two images for the same view.
- Jul 23, 2015 · Class II · Z-2551-2016: The software is unable to accurately determine the calcium score of scans with a slice thickness not equal to 3 mm.

## Indications for use
The DR Systems PACS, Release 6.1 is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems. The DR Systems PACS interfaces to various storage and printing devices using DICOM or similar interface standards. The DR Systems PACS displays, stores, prints, and telecommunicates images from a number of medical modalities, including but not limited to MRI, CT, US, PET, DXA (bone densitometry), imaging, computed radiography, digital radiography, digitized films, digital photographs, mammographic images, and processed data from FDA-cleared third party image processing systems, including FDA-cleared systems for computer-aided detection and advanced image processing (e.g. 3-D processed images such as those produced by Voxar Corp.). Lossy compressed mammographic images must not be used for primary diagnostic interpretation unless approved for use in digital mammography. Display monitors used for primary diagnostic interpretation of mammographic images must be approved for use in digital mammography.

Source page: https://510kreport.com/device/K041935
Methodology: https://510kreport.com/methodology