# DEN100016: Prostate Mechanical Imager

- Pathway: De Novo (Post-NSE)
- Applicant: Artann Laboratories, Inc.
- Decided: Apr 27, 2012 after 707 days
- Product code: OQT (Prostate Lesion, Documentation, System)
- Device class: 2
- Regulation: 21 CFR 876.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
the production of an elasticity image of the prostate as an aid in documenting prostate abnormalities that were previously identified by digital rectal examination (DRE). The device utilizes a transrectal probe with pressure sensor arrays and a motion tracking system and provides real-time elasticity images of the prostate. This device is limited to use as a documentation tool and therefore is not to be used for cancer diagnosis or for any other diagnostic purpose. This device is only to be used to image and document an abnormality that was already identified by DRE. Clinical management decisions are not to be made on the basis of information from the PMI device, but rather on the basis of the DRE. If there is disagreement between the DRE and the recorded image produced by the device, patient management decisions are to be based on the DRE and other available clinical and diagnostic information (e.g., prostate-specific antigen (PSA) levels) in accordance with standard medical practice.

Source page: https://510kreport.com/device/DEN100016
Methodology: https://510kreport.com/methodology