# K100372: Safect Model Ver 1.0

- Pathway: 510(k) (Traditional)
- Applicant: Medic Vision Brain Technologies, Ltd.
- Decided: Dec 14, 2010 after 305 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: 3 generations back to K922470 (1992). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024028: Sharp View Image Enhancement System, Context Vision AB (2003) Summary page 1.

## Most influential descendants
- K161625: PixelShine (2016), 0 descendants of its own

## Indications for use
The SafeCT is intended for networking, communication, processing and enhancement of CT images in DICOM format. It is specifically indicated for assisting professional radiologists and specialists in reaching their own diagnosis. The device processing is not effective for lesion, mass or abnormalities of sizes less than 3 mm. The SafeCT is not intended for use with or for diagnostic interpretation of Mammography images

Source page: https://510kreport.com/device/K100372
Methodology: https://510kreport.com/methodology