510(k) · Cleared
Cleared6MP Color LCD Monitor, RadiForce RX660, RX660-AR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eizo Corporation · PGY Display, Diagnostic Radiology
Cleared on Dec 15, 2016 as substantially equivalent to K134002 (Eizo Corporation, 2014) after a 17-day review. Its family tree reaches back 5 generations to 2004. 3 later devices descend from it.
- Decided
- Dec 15, 2016
- Review
- 17 days
- Class
- Class II
- Product code
- PGY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K033466 (2004). 3 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK033466 Color LCD Display, Model Radiforce R22Eizo Nanao Corporation · 2004
- 4 generations backK052344 Color LCD Monitor, Model Radioforce R31 & R31-CEizo Nanao Corporation · 2005
- 3 generations backK090045 Color LCD Monitor, Radiforce RX320Eizo Nanao Corporation · 2009
- 2 generations backK113562 3MP Color LCD Monitor, Radiforce RX340Eizo Nanao Corporation · 2012
- 1 generation backK134002 6MP Color LCD Monitor, Radiforce RX650Eizo Corporation · 2014 · Recalled
- This deviceK163335 6MP Color LCD Monitor, RadiForce RX660, RX660-AREizo Corporation · 2016
- Descendant · cites it directly · 0 of its ownK241441 RadiForce RX670; RadiForce RX670-AREizo Corporation · 2024
- Descendant · cites it directly · 0 of its ownK222208 Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30DQingdao Hisense Medical Equipment Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK222722 CW60NWide Corporation · 2022
Most influential descendants
Showing 3 of 3 · See all- K241441RadiForce RX670; RadiForce RX670-AREizo Corporation · 2024 · cites it directly0descendants
- K222208Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30DQingdao Hisense Medical Equipment Co., Ltd. · 2022 · cites it directly0descendants
- K222722CW60NWide Corporation · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K033466 | Color LCD Display, Model Radiforce R22 | Eizo Nanao Corporation | 2004 | — |
| −4 | K052344 | Color LCD Monitor, Model Radioforce R31 & R31-C | Eizo Nanao Corporation | 2005 | — |
| −3 | K090045 | Color LCD Monitor, Radiforce RX320 | Eizo Nanao Corporation | 2009 | — |
| −2 | K113562 | 3MP Color LCD Monitor, Radiforce RX340 | Eizo Nanao Corporation | 2012 | — |
| −1 | K134002 | 6MP Color LCD Monitor, Radiforce RX650 | Eizo Corporation | 2014 | 1 |
| 0 (this device) | K163335 | 6MP Color LCD Monitor, RadiForce RX660, RX660-AR | Eizo Corporation | 2016 | — |
| +1 | K241441 | RadiForce RX670; RadiForce RX670-AR | Eizo Corporation | 2024 | — |
| +1 | K222208 | Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D | Qingdao Hisense Medical Equipment Co., Ltd. | 2022 | — |
| +1 | K222722 | CW60N | Wide Corporation | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K134002 | 6MP Color LCD Monitor, Radiforce RX650Summary page 4…lay, Diagnostic Radiology • Regulation Number: 21 CFR 892.2050, Product Code PGY 5. Predicate Device 6MP Color LCD Monitor, RadiForce RX650 (K134002) Section 05 Traditional 510(k) Summary_RX660_c: Page 1 of 5 === Page 5 ==… | 2014 |
What descends from it? (3)
3 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 12 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K241441 (Eizo Corporation, 2024) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K134002.
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?
This product is intended to be used in displaying and viewing digital images for review, analysis and diagnosis by trained medical practitioners. It does not support the display of mammography images for diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163335 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163335: 6MP Color LCD Monitor, RadiForce RX660, RX660-AR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163335
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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