# K133357: Charruapacs System

- Pathway: 510(k) (Traditional)
- Applicant: Charruasoft SA
- Decided: Nov 25, 2013 after 25 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K945188 (1995). 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)
- K080334: Instarad, Medsphere Technologies Pvt, Ltd. (2008) Summary page 3.

## Indications for use
CharruaPACS System™ is a software based device that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways, etc.). Images and data can be captured, stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA cleared monitor.

Source page: https://510kreport.com/device/K133357
Methodology: https://510kreport.com/methodology