# K142337: Blackford Analysis Registration Product Family

- Pathway: 510(k) (Traditional)
- Applicant: Blackford Analysis, Ltd.
- Decided: Mar 19, 2015 after 210 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K202718: Qmenta Care Platform Family (2021), 0 descendants of its own

## Indications for use
The Blackford Registration Product Family consists of two components: 1. A Workflow Server that calculates DICOM registration objects from CT and MR modality data, and also PET/CT data via using the CT data for registration. 2. A localizer tool that works across studies, or series in the same study within a different frame of reference. The first intended clinical use, when reading studies of the above modalities, is to aid navigation through, and comparative interpretation of, a target series with respect to a source series. Normally, the source series will be within a current study and the target series will be within a prior study. However they may also be within the same study but have a different frame of reference. Aiding navigation may include, but is not limited to, indicating corresponding anatomical locations, synchronized scrolling, matching orientations and/or reference lines in reformatted series and fusing two images from source and target series. The second clinical use is to aid presentation of change between cross-sectional radiographic studies to clinical colleagues and patients. Registration-aided interpretation of images should be carried out by a suitably qualified physician, who will base their diagnoses on training and protocols that do not necessarily rely on registration for navigation.

Source page: https://510kreport.com/device/K142337
Methodology: https://510kreport.com/methodology