# K223484: IGAR System (1001.A)

- Pathway: 510(k) (Traditional)
- Applicant: Insight Medbotics, Inc.
- Decided: Jul 20, 2023 after 244 days
- Product code: MOS (Coil, Magnetic Resonance, Specialty)
- Device class: 2
- Regulation: 21 CFR 892.1000
- 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 K993776 (1999). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100113: Vanguard Breast Mri Auxiliary Table with 16 Channel Coil Array for GE 3T Mri System, Model 4000451-51, Sentinelle Medical, Inc. (2010) Summary page 4.

## Indications for use
The IGAR System is intended to acquire magnetic resonance (MR) images of the breast anatomy and permits access to the breast for biopsy and localization procedures. A front breast restraint immobilizes the patient’s breast to permit three-dimensional MR imaging to identify the location of the breast lesion(s) for the purposes of selecting a target for biopsy. The IGAR System guides a breast biopsy tool to the target location of the breast from which a biopsy can be obtained. The IGAR System is intended to be used by qualified professionals.

Source page: https://510kreport.com/device/K223484
Methodology: https://510kreport.com/methodology