510(k) · Cleared
ClearedProstatID
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scanmed, LLC · QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
Cleared on Jul 8, 2022 as substantially equivalent to K193229 (Screenpoint Medical B.V., 2020) after a 310-day review. Its family tree reaches back 3 generations to 2018. 2 later devices descend from it.
- Decided
- Jul 8, 2022
- Review
- 310 days
- Class
- Class II
- Product code
- QDQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN180005 (2018). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backDEN180005 OsteoDetectImagen Technologies, Inc. · 2018
- 2 generations backK181704 TransparaScreenpoint Medical B.V. · 2018
- 1 generation backK193229 TransparaScreenpoint Medical B.V. · 2020
- This deviceK212783 ProstatIDScanmed, LLC · 2022
- Descendant · cites it directly · 0 of its ownK253682 DeepHealth ProstateAIQuantib B.V. · 2026
- Descendant · cites it directly · 0 of its ownK242683 QP-Prostate® CADQuibim S.L. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN180005 | OsteoDetect | Imagen Technologies, Inc. | 2018 | — |
| −2 | K181704 | Transpara | Screenpoint Medical B.V. | 2018 | — |
| −1 | K193229 | Transpara | Screenpoint Medical B.V. | 2020 | — |
| 0 (this device) | K212783 | ProstatID | Scanmed, LLC | 2022 | — |
| +1 | K253682 | DeepHealth ProstateAI | Quantib B.V. | 2026 | — |
| +1 | K242683 | QP-Prostate® CAD | Quibim S.L. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) 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 QDQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QDQ device
- #1 K241831 Transpara (2.1.0)score 15.6 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K193229 | TransparaSummary page 5…Common Name: ProstatIDTM MRI Diagnostic Aid for Prostate Cancer III. PREDICATE DEVICE Name of Predicate: TransparaTM 1.6.0 Predicate 510(k) Number: K193229 Applicant: ScreenPoint Medical B.V. Regulation Number: 21 CFR 892.2090 Regulation Name: Radiological Compute… | 2020 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
What does this lineage say?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K253682 (Quantib B.V., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K193229.
How does its category compare?
All QDQ devicesQDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · QDQ
10so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QDQ
216in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QDQ
No recall names QDQ since 2007.
Adverse event reports per year · QDQ
No MAUDE report names QDQ 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 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 3 | 173 | 0 | 0 |
| 2021 | 5 | 169 | 0 | 0 |
| 2022 | 4 | 131 | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 7 | 153 | 0 | 0 |
| 2025 | 5 | 216 | 0 | 0 |
| 2026 | 10 | 154 | 0 | — |
What is it indicated for?
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…
Read the full statement (344 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212783 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212783: ProstatID.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212783
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026