# K253794: Prostate Core

- Pathway: 510(k) (Traditional)
- Applicant: Lucida Medical, Ltd.
- Decided: Aug 10, 2026 after 255 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K971684 (1997). 49 ancestors in all.
No later device cites it as a predicate yet.
3 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203582: QUIBIM Precision Prostate (qp-Prostate), Quibim S.L. (2021) Summary page 5.

## Indications for use
Prostate Core™ is a software medical device intended for automatic segmentation and volumetric quantification of the prostate. Prostate Core™ is intended to be used by trained healthcare professionals as an aid to reading/assessing prostate MRI images of adult males aged 22 or over. Prostate Core™ is not intended as a replacement for clinical review or of the judgement of healthcare professionals. The software does not modify the original medical images and does not provide a direct diagnosis. Prostate Core™ is not intended for patients: * who received a prostate biopsy within 6 weeks before the MRI examination * with prior prostate or urethral treatment or surgery that substantially affects the prostate gland * whose MRI scan quality is severely impaired, for example by patient motion, breathing, peristaltic motion, rectal gas, or metallic implants such as hip prostheses * where a radiologist considers that the MRI examination is not of diagnostic quality * with MRI examinations that substantially deviate from PI-RADS®v2.1 scanning protocols * whose MRI images have been captured using an endo-rectal coil.

Source page: https://510kreport.com/device/K253794
Methodology: https://510kreport.com/methodology