510(k) · Cleared
Cleared5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jvckenwood Corporation · PGY Display, Diagnostic Radiology
Cleared on Feb 23, 2016 as substantially equivalent to K151883 (Eizo Corporation, 2015) after an 18-day review. Its family tree reaches back 2 generations to 2011. 12 later devices descend from it.
- Decided
- Feb 23, 2016
- Review
- 18 days
- Class
- Class II
- Product code
- PGY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K103792 (2011). 12 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK103792 Barco Mammo TomosynthesisBarco N.V. · 2011
- 1 generation backK151883 5MP Monochrome LCD Monitor, RadiForce GX540Eizo Corporation · 2015
- This deviceK160326 5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2…Jvckenwood Corporation · 2016
- Descendant · cites it directly · 6 of its ownK191137 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500Jvckenwood Corporation · 2019
- Descendant · 2 generations on · 2 of its ownK200864 5MP Color LCD Monitors C53S+, C53SP+, 5MP Monochrome LCD Monitors…Shenzhen Beacon Display Technology Co., Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK170781 MX50N (MX50YQS)Wide Corporation · 2017
- Descendant · cites it directly · 1 of its ownK170783 CX50N (CX50YQS)Wide Corporation · 2017
- Descendant · 3 generations on · 0 of its ownK253242 LCD Monitor (C1216W, C822W, C821W)Shenzhen Beacon Display Technology Co., Ltd. · 2025
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K1911375MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500Jvckenwood Corporation · 2019 · cites it directly6descendants
- K2008645MP Color LCD Monitors C53S+, C53SP+, 5MP Monochrome LCD Monitors G53S+, G53SP+Shenzhen Beacon Display Technology Co., Ltd. · 2020 · 2 generations on2descendants
- K170781MX50N (MX50YQS)Wide Corporation · 2017 · cites it directly1descendant
- K170783CX50N (CX50YQS)Wide Corporation · 2017 · cites it directly1descendant
- K253242LCD Monitor (C1216W, C822W, C821W)Shenzhen Beacon Display Technology Co., Ltd. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K103792 | Barco Mammo Tomosynthesis | Barco N.V. | 2011 | — |
| −1 | K151883 | 5MP Monochrome LCD Monitor, RadiForce GX540 | Eizo Corporation | 2015 | — |
| 0 (this device) | K160326 | 5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550) | Jvckenwood Corporation | 2016 | — |
| +1 | K191137 | 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500 | Jvckenwood Corporation | 2019 | — |
| +2 | K200864 | 5MP Color LCD Monitors C53S+, C53SP+, 5MP Monochrome LCD Monitors G53S+, G53SP+ | Shenzhen Beacon Display Technology Co., Ltd. | 2020 | — |
| +1 | K170781 | MX50N (MX50YQS) | Wide Corporation | 2017 | — |
| +1 | K170783 | CX50N (CX50YQS) | Wide Corporation | 2017 | — |
| +3 | K253242 | LCD Monitor (C1216W, C822W, C821W) | Shenzhen Beacon Display Technology Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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 PGY? 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 PGY device
- #1 K261213 Medical Monitor (40HT513D)score 13.9 · 9 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 |
|---|---|---|---|
| * | K151883 | 5MP Monochrome LCD Monitor, RadiForce GX540Summary page 4…diology Devices Sec. 892.2050 Picture Archiving and Communication System) Predicate Device: 5MP Monochrome LCD Monitor, RadiForce GX540 (K151883) Device Description: MS55i2 (ML21055, MD211G5) is a 21.3 inch (54 cm) monochrome LCD monitor and C… | 2015 |
What descends from it? (12)
See all 124 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 5 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K191137 (Jvckenwood Corporation, 2019) has gone furthest, with 6 descendants of its own.
- 5 other devices also cite its predicate K151883.
How does its category compare?
All PGY devicesPGY Display, Diagnostic Radiology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · PGY
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PGY
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PGY
No recall names PGY since 2007.
Adverse event reports per year · PGY
1in 2017
MAUDE reports naming product code PGY, not matched to any one device; reports are not rates.
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 | 14 | 24 | 0 | 0 |
| 2015 | 16 | 31 | 0 | 0 |
| 2016 | 18 | 27 | 0 | 0 |
| 2017 | 11 | 30 | 0 | 1 |
| 2018 | 5 | 28 | 0 | 0 |
| 2019 | 11 | 58 | 0 | 0 |
| 2020 | 12 | 61 | 0 | 0 |
| 2021 | 7 | 77 | 0 | 0 |
| 2022 | 10 | 60 | 0 | 0 |
| 2023 | 17 | 60 | 0 | 0 |
| 2024 | 10 | 53 | 0 | 0 |
| 2025 | 3 | 59 | 0 | 0 |
| 2026 | 4 | 48 | 0 | — |
What is it indicated for?
5MP Monochrome LCD Monitor MS55i2 (ML21055, MD211G5) and
5MP Color LCD Monitor CCL550i2 (CL21550)
are intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners.
They are to be used in digital mammography PACS, modalities including FFDM, and breast tomosynthensis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160326 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160326: 5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160326
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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