# K212783: ProstatID

- Pathway: 510(k) (Traditional)
- Applicant: Scanmed, LLC
- Decided: Jul 8, 2022 after 310 days
- Product code: QDQ (Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer)
- Device class: 2
- Regulation: 21 CFR 892.2090
- 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 DEN180005 (2018). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193229: Transpara, Screenpoint Medical B.V. (2020) Summary page 5.

## Most influential descendants
- K253682: DeepHealth ProstateAI (2026), 0 descendants of its own
- K242683: QP-Prostate® CAD (2025), 0 descendants of its own

## Indications for use
ProstatlDTM is a radiological computer assisted detection (CADe) and diagnostic (CADx) software device for use in a healthcare facility or hospital to assist trained radiologists in the detection, assessment and characterization of prostate abnormalities, including cancer lesions using MR image data with the following indications for use. ProstatlD analyzes T2W, DWI and ADC MRI data. ProstatlD does not include DCE images in its analysis. ProstatlD software is intended for use as a concurrent reading aid for physicians interpreting prostate MRI exams of patients presented for high-risk screening or diagnostic imaging, from compatible MRI systems, to identify regions suspicious for prostate cancer and assess their likelihood of malignancy. Outputs of the device include the volume of the prostate and locations, as well as the extent of suspect lesions, with index scores indicating the likelihood that cancer is present, as well as an exam score by way of PI-RADS interpretation suggestion. "Extent of suspect lesions" refers to both the assessment of the boundary of a particular abnormality, as well as identification of multiple abnormalities. In cases where multiple abnormalities are present, ProstatlD can be used to assess each abnormality independently. Outputs of this device should be interpreted with all available MR data consistent with ACR clinical recommendations (e.g., dynamic contract enhanced images if available) in context of PI-RADs v2, and in conjunction with bi-parametric MRI acquired with either surface or endorectal MRI accessory coils from compatible MRI systems. Analysis by ProstatlD is not intended as a replacement for interpreting prostate abnormalities using MR image data consistent with clinical recommendations (including DCE); nor should patient management decisions be made solely on the basis of ProstatlD. INTENDED USER POPULATION Intended users ofProstatlD are physicians qualified to read and interpret prostate MRI exams consistent with ACR recommendations in the context of PI-RADS v2. INTENDED PATIENT POPULATION The device is intended to be used in the population of biological adult males with a prostate gland undergoing screening or clinical MRI exams. This includes biological males with clinical indicators suggestive of possible prostate cancer or with family history of prostate cancer.

Source page: https://510kreport.com/device/K212783
Methodology: https://510kreport.com/methodology