# K033825: Orthopacs

- Pathway: 510(k) (Traditional)
- Applicant: Etrauma.Com Corp.
- Decided: Feb 2, 2004 after 54 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K904519 (1991). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031590: Sectra Orthopedic Package, Sectra-Imtec AB (2003) Summary page 1.
- K022881: Cedara I-Softview, Cedara Software Corp. (2002) Summary page 1.

## Recalls of this device
- Jan 31, 2016 · Class II · Z-2159-2016: Potential data loss occurs as a result of product archiving not working properly.
- Jan 30, 2016 · Class II · Z-2144-2016: Potential data loss occurs as a result of the software archiving not working properly.
- Jan 30, 2016 · Class II · Z-2531-2016: Studies that are viewed in iConnect Access that originate on Merge PACS / Ortho PACS may not display the correct current patient demographics if there has been a PDE (Patient / Study Demographic Edit)
- Jan 30, 2016 · Class II · Z-2532-2016: Studies that are viewed in iConnect Access that originate on Merge PACS / Ortho PACS may not display the correct current patient demographics if there has been a PDE (Patient / Study Demographic Edit)

## Indications for use
OrthoPACS is intended for the manipulation and displaying of medical images by a suitable licensed and qualified healthcare professional. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. OrthoPACS also uses such images, in conjunction with templates for prosthetic devices, for the purposes of choosing the nature and characteristics of the prosthetic device to be used when planning a potential surgical procedure.

Source page: https://510kreport.com/device/K033825
Methodology: https://510kreport.com/methodology