510(k) · Cleared
Cleared3MP Monochrome Digital Mammography LCD Monitor MS-S300
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 21, 2020 as substantially equivalent to K133686 (Jvckenwood Corporation, 2014) after a 30-day review. Its family tree reaches back 11 generations to 1991.
- Decided
- Feb 21, 2020
- Review
- 30 days
- Class
- Class II
- Product code
- PGY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K913770 (1991). 23 ancestors in all, the oldest K885042 (1988). No later device cites it as a predicate yet.
- Root · 11 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 7 generations between
- 3 generations backK090947 21.3 (54 CM) Monochrome Digital Mammography LCD Monitor, Model…Totoku Electric Co., Ltd. · 2010
- 2 generations backK112145 Monochrome Digital Mammography LCD Monitor MS33I2Totoku Electric Co., Ltd. · 2011
- 1 generation backK133686 21.3 INCH (54 CM) INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR…Jvckenwood Corporation · 2014
- This deviceK200161 3MP Monochrome Digital Mammography LCD Monitor MS-S300Jvckenwood Corporation · 2020
Show all 11 generations
- Root · 11 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 10 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 9 generations backK972701 Barco MWD 321 Medical Workstation DisplayBarco NV Display Systems · 1998
- 8 generations backK980541 Barco MGD 521 5 Megapixel Diagnostic DisplayBarco NV Display Systems · 1998
- 7 generations backK033859 Barcoview MGD 521M Digital Mammography DisplayBarco NV Barcoview · 2004
- 6 generations backK041737 5M Monochrome Digital Mammography LCD Monitor ME511L (MDL2105A)Totoku Electric Co., Ltd. · 2004
- 5 generations backK061447 5M Monochrome Digital Mammography LCD Monitor MDL2116A (ME551I2)Totoku Electric Co., Ltd. · 2006
- 4 generations backK071794 15M Monochrome Digital Mammography LCD Monitor MDL2123A (MS51I2)Totoku Electric Co., Ltd. · 2008
- 3 generations backK090947 21.3 (54 CM) Monochrome Digital Mammography LCD Monitor, Model…Totoku Electric Co., Ltd. · 2010
- 2 generations backK112145 Monochrome Digital Mammography LCD Monitor MS33I2Totoku Electric Co., Ltd. · 2011
- 1 generation backK133686 21.3 INCH (54 CM) INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR…Jvckenwood Corporation · 2014
- This deviceK200161 3MP Monochrome Digital Mammography LCD Monitor MS-S300Jvckenwood Corporation · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −10 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −9 | K972701 | Barco MWD 321 Medical Workstation Display | Barco NV Display Systems | 1998 | — |
| −8 | K980541 | Barco MGD 521 5 Megapixel Diagnostic Display | Barco NV Display Systems | 1998 | — |
| −7 | K033859 | Barcoview MGD 521M Digital Mammography Display | Barco NV Barcoview | 2004 | — |
| −6 | K041737 | 5M Monochrome Digital Mammography LCD Monitor ME511L (MDL2105A) | Totoku Electric Co., Ltd. | 2004 | — |
| −5 | K061447 | 5M Monochrome Digital Mammography LCD Monitor MDL2116A (ME551I2) | Totoku Electric Co., Ltd. | 2006 | — |
| −4 | K071794 | 15M Monochrome Digital Mammography LCD Monitor MDL2123A (MS51I2) | Totoku Electric Co., Ltd. | 2008 | — |
| −3 | K090947 | 21.3 (54 CM) Monochrome Digital Mammography LCD Monitor, Model MS3112 (MDL2128A) | Totoku Electric Co., Ltd. | 2010 | — |
| −2 | K112145 | Monochrome Digital Mammography LCD Monitor MS33I2 | Totoku Electric Co., Ltd. | 2011 | — |
| −1 | K133686 | 21.3 INCH (54 CM) INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS35i2… | Jvckenwood Corporation | 2014 | — |
| 0 (this device) | K200161 | 3MP Monochrome Digital Mammography LCD Monitor MS-S300 | Jvckenwood Corporation | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 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 |
|---|---|---|---|
| * | K133686 | 21.3 INCH (54 CM) INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS35i2 (ML21035)Summary page 4…Sec. 892.2050 Picture Archiving and Communication System) Predicate Device: 21.3 inch (54cm) Monochrome LCD Monitor MS35i2 (MS35i2/ K133686) Device Description: 21.3 inch Monochrome Digital Mammography LCD Monitor 2048 x 1536 (landscape),… | 2014 |
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?
- The line of descent spans 29 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- None of the 23 ancestors has a recall.
How does its category compare?
All PGY devicesPGY Display, Diagnostic Radiology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
MS-S300 is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. It's intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K200161 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200161: 3MP Monochrome Digital Mammography LCD Monitor MS-S300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200161
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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