# K052478: MFCD 1219, MFCD 1219 TS

- Pathway: 510(k) (Traditional)
- Applicant: Barcoview
- Decided: Sep 28, 2005 after 19 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: 2 generations back to K000294 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040158: MFCD 2320, Barco N.V. (2004) Summary page 1.

## Indications for use
The MFCD 1219 is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography. The MFCD 1219 IS is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.

Source page: https://510kreport.com/device/K052478
Methodology: https://510kreport.com/methodology