De Novo · Granted
GrantedProstate Mechanical Imager
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Artann Laboratories, Inc. · OQT Prostate Lesion, Documentation, System
Granted on Apr 27, 2012 as a new device type through De Novo after a 707-day review.
- Decided
- Apr 27, 2012
- Review
- 707 days
- Class
- Class II
- Product code
- OQT
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OQT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All OQT devicesOQT Prostate Lesion, Documentation, System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · OQT
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · OQT
Too few OQT 510(k)s in any year since 2007 to give a median.
Recalls per year · OQT
No recall names OQT since 2007.
Adverse event reports per year · OQT
No MAUDE report names OQT since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (161 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN100016 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN100016: Prostate Mechanical Imager.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN100016
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026