510(k) · Cleared
ClearedMMPC-4127F1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Barco N.V. · PZZ Digital Pathology Display
Cleared on Dec 21, 2017 as substantially equivalent to DEN160056 (Philips Medical Systems Nederland B.V., 2017) after an 87-day review. Its family tree reaches back 1 generation to 2017.
- Decided
- Dec 21, 2017
- Review
- 87 days
- Class
- Class II
- Product code
- PZZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN160056 (2017). No later device cites it as a predicate yet.
- Root · 1 generation backDEN160056 Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V. · 2017
- This deviceK172922 MMPC-4127F1Barco N.V. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN160056 | Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. | 2017 | — |
| 0 (this device) | K172922 | MMPC-4127F1 | Barco N.V. | 2017 | — |
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 PZZ? 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 PZZ device
- #1 K242545 RadiForce MX317W-PAscore 10.3 · 4 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | DEN160056 | Philips IntelliSite Pathology SolutionSummary page 4…864.3700 5. Predicate MMPC-4127 (PP27QHDCR), display component of device Philips IntelliSite Pathology Solution, cleared under DeNovo no. DEN160056 The MMPC-4127F1, also marketed as the PP27QHD, is a stabilized, color-calibrated 6. Device… | 2017 |
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.
What does this lineage say?
- Its one ancestor has no recall.
- 8 other devices also cite its predicate DEN160056.
How does its category compare?
All PZZ devicesPZZ Digital Pathology Display: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PZZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PZZ
Too few PZZ 510(k)s in any year since 2007 to give a median.
Recalls per year · PZZ
No recall names PZZ since 2007.
Adverse event reports per year · PZZ
No MAUDE report names PZZ 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 | 1 | — | 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 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Barco MMPC-4127F1 (PP27QHD) device is intended for in vitro diagnostic use to display digital images of histopathology slides acquired from IVD-labeled whole-slide imaging scanners that have been validated for use with this device, for review and interpretation by pathologists. The display is not intended for use with digital images from frozen section, cytology, or non-formalin-fixed, paraffin embedded (non-FFPE) hematopathology specimens.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172922 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172922: MMPC-4127F1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172922
Report an extraction error
Are you the manufacturer?
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