# K023864: Performa Stereo

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentarium Corp. Imaging Division
- Decided: Jan 9, 2003 after 50 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 K884107 (1989). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934478: Alpha Stereo, Instrumentarium Corp. (1995) Summary page 1.
- K941191: Real Time Stereotix, GE Medical Systems (1995) Summary page 1.
- K884107: Stereotactic Biopsy Attachment, Siemens Medical Solutions USA, Inc. (1989) Summary page 1.

## Indications for use
Performa Stereo is intended to be used for breast biopsy or lesion marking with the base mammographic system Performa with stereo adapter.

Source page: https://510kreport.com/device/K023864
Methodology: https://510kreport.com/methodology