# K072873: LBS-63-16 Breast Array Coil

- Pathway: 510(k) (Special)
- Applicant: Invivo
- Decided: Nov 16, 2007 after 38 days
- Product code: MOS (Coil, Magnetic Resonance, Specialty)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 4 (0 Class I)
- 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K262330: dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T (2026), 0 descendants of its own

## Recalls of this device
- Nov 4, 2024 · Class II · Z-0537-2025: Potential safety issue where a patient may be harmed while preparing for or during a scan.
- Nov 4, 2024 · Class II · Z-0538-2025: Potential safety issue where a patient may be harmed while preparing for or during a scan.
- Nov 4, 2024 · Class II · Z-0541-2025: Potential safety issue where a patient may be harmed while preparing for or during a scan.
- Nov 4, 2024 · Class II · Z-0543-2025: Potential safety issue where a patient may be harmed while preparing for or during a scan.

Source page: https://510kreport.com/device/K072873
Methodology: https://510kreport.com/methodology