# K232569: Caremibrain

- Pathway: 510(k) (Traditional)
- Applicant: General Equipment For Medical Imaging, S.A.
- Decided: Sep 21, 2023 after 28 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K091269 (2009). 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)
- K210450: BBX-PET Scanner, Prescient Imaging, LLC (2021) Summary page 5.

## Indications for use
CareMiBrain is dedicated brain PET scanner, and intended to obtain Positron Emission Tomography (PET) images of human brain to detect abnormal pattern of distribution of radioactivity after injection of a positron emitting radiopharmaceutical. This device is to be used by trained healthcare professionals. This information can assist in research, diagnosis, therapeutic planning and therapeutic outcome assessment.

Source page: https://510kreport.com/device/K232569
Methodology: https://510kreport.com/methodology