# K022275: Delta 32; Delta 32 Tact

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentarium Corp. Imaging Division
- Decided: Sep 12, 2002 after 59 days
- Product code: IZH (System, X-Ray, Mammographic)
- Device class: 2
- Regulation: 21 CFR 892.1710
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K000976 (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)
- K002472: Delta 32 and Delta 32 Tact, Instrumentarium Imaging, Inc. (2000) Summary page 1.
- K000976: Diamond (Mammographic X-Ray System), Instrumentarium Imaging, Inc. (2000) Summary page 1.

## Indications for use
Delta 32 and Delta 32 TACT@ are intended to be used for diagnostic digital spot and 3D imaging, and optionally for digital stereotactic breast biopsy. Delta 32 and Delta 32 TACT@ are intended to be used with the base mammographic system Diamond. However, a PC workstation of Delta 32 and Delta 32 TACT@ can also be used as stand-alone for viewing images taken by Delta 32 and Delta 32 TACT@. The TACT@ add-on provides means for digital 3D spot imaging using 2D projection images acquired with the system.

Source page: https://510kreport.com/device/K022275
Methodology: https://510kreport.com/methodology