510(k) · Cleared
ClearedKrystalrad 560 (Flaatz 560)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicatech USA · KPR System, X-Ray, Stationary
Cleared on Jan 3, 2011 as substantially equivalent to K080064 (Drtech Corp., 2008) after a 144-day review. Its family tree reaches back 2 generations to 2007. 3 later devices descend from it.
- Decided
- Jan 3, 2011
- Review
- 144 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K063710 (2007). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK063710 Saturn 9000New Medical Co., Ltd. · 2007
- 1 generation backK080064 Flaatz 750Drtech Corp. · 2008
- This deviceK102284 Krystalrad 560 (Flaatz 560)Medicatech USA · 2011
- Descendant · cites it directly · 2 of its ownK111583 Flaatz 560Drtech Corp. · 2011
- Descendant · 2 generations on · 0 of its ownK132842 Flaatz 600 Series (Flaatz 600/601)Drtech Corp. · 2014
- Descendant · 2 generations on · 0 of its ownK113855 Panorad, Panorad SLImix Adr Finland OY · 2012
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K063710 | Saturn 9000 | New Medical Co., Ltd. | 2007 | — |
| −1 | K080064 | Flaatz 750 | Drtech Corp. | 2008 | — |
| 0 (this device) | K102284 | Krystalrad 560 (Flaatz 560) | Medicatech USA | 2011 | — |
| +1 | K111583 | Flaatz 560 | Drtech Corp. | 2011 | — |
| +2 | K132842 | Flaatz 600 Series (Flaatz 600/601) | Drtech Corp. | 2014 | — |
| +2 | K113855 | Panorad, Panorad SL | Imix Adr Finland OY | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 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 KPR? 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 KPR device
- #1 K242119 Innovision-Exiiscore 17.0 · 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 |
|---|---|---|---|
| * | K080064 | Flaatz 750Summary page 1…MQB Regulation Number: 892.16890 Date Prepared De~eb~nihf15, 2010 Substantial Equivalence claimed to: DRTech FLAATZ 750 (K080064) Device Description The KrystalRad 560 (FLAATZ 560) System is a flat-panel type digital X-ray detector that captures projection… | 2008 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111583 | Flaatz 560 | 2011 | 2 |
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 2.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K111583 (Drtech Corp., 2011) has gone furthest, with 2 descendants of its own.
- 7 other devices also cite its predicate K080064.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · KPR
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPR
155in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPR
7in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KPR
39in 2025
MAUDE reports naming product code KPR, 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 | 12 | 31 | 10 | 120 |
| 2008 | 15 | 48 | 10 | 95 |
| 2009 | 9 | 35 | 5 | 61 |
| 2010 | 9 | 126 | 3 | 82 |
| 2011 | 9 | 152 | 5 | 103 |
| 2012 | 11 | 58 | 1 | 74 |
| 2013 | 5 | 163 | 5 | 24 |
| 2014 | 10 | 108 | 8 | 34 |
| 2015 | 18 | 81 | 1 | 59 |
| 2016 | 11 | 84 | 4 | 18 |
| 2017 | 6 | 75 | 3 | 31 |
| 2018 | 15 | 30 | 4 | 36 |
| 2019 | 12 | 33 | 1 | 77 |
| 2020 | 16 | 39 | 1 | 41 |
| 2021 | 6 | 55 | 0 | 37 |
| 2022 | 8 | 43 | 2 | 27 |
| 2023 | 9 | 76 | 4 | 39 |
| 2024 | 11 | 162 | 1 | 34 |
| 2025 | 8 | 155 | 7 | 39 |
| 2026 | 6 | 197 | 0 | — |
What is it indicated for?
The KrystalRad 560 (FLAATZ 560) Digital X-Ray Systems is indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammographic applications).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102284 · printed Nov 5, 2026
Cite this page
510(k) Report. “K102284: Krystalrad 560 (Flaatz 560).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K102284
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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