510(k) · Cleared
ClearedAquarius 8600
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imaging Dynamics Company, Ltd. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Feb 22, 2017 as substantially equivalent to K070079 (Imaging Dynamics Company, Ltd., 2007) after a 30-day review. Its family tree reaches back 1 generation to 2007. 4 later devices descend from it.
- Decided
- Feb 22, 2017
- Review
- 30 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K070079 (2007). 4 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK070079 X3C Digital Radiographic DetectorImaging Dynamics Company, Ltd. · 2007
- This deviceK170202 Aquarius 8600Imaging Dynamics Company, Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK181565 Aquarius 8600 Digital Radiography SensorBiokinemetrics, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK173273 Aquarius 8600 1417WCI; Aquarius 8600 1717WCIImaging Dynamics Company, Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK171169 Aquarius 8600 1417TG and Aquarius 8600 1717TGImaging Dynamics Company, Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK171175 Aquarius 8600 1417WCImaging Dynamics Company, Ltd. · 2017
Most influential descendants
Showing 4 of 4 · See all- K181565Aquarius 8600 Digital Radiography SensorBiokinemetrics, Inc. · 2018 · cites it directly0descendants
- K173273Aquarius 8600 1417WCI; Aquarius 8600 1717WCIImaging Dynamics Company, Ltd. · 2017 · cites it directly0descendants
- K171169Aquarius 8600 1417TG and Aquarius 8600 1717TGImaging Dynamics Company, Ltd. · 2017 · cites it directly0descendants
- K171175Aquarius 8600 1417WCImaging Dynamics Company, Ltd. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K070079 | X3C Digital Radiographic Detector | Imaging Dynamics Company, Ltd. | 2007 | — |
| 0 (this device) | K170202 | Aquarius 8600 | Imaging Dynamics Company, Ltd. | 2017 | — |
| +1 | K181565 | Aquarius 8600 Digital Radiography Sensor | Biokinemetrics, Inc. | 2018 | — |
| +1 | K173273 | Aquarius 8600 1417WCI; Aquarius 8600 1717WCI | Imaging Dynamics Company, Ltd. | 2017 | — |
| +1 | K171169 | Aquarius 8600 1417TG and Aquarius 8600 1717TG | Imaging Dynamics Company, Ltd. | 2017 | — |
| +1 | K171175 | Aquarius 8600 1417WC | Imaging Dynamics Company, Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 3 | 0 |
| 2018 | 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 MQB? 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 MQB device
- #1 K201528 Yushan X-Ray Flat Panel Detector with DROCscore 21.5 · 12 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 |
|---|---|---|---|
| * | K070079 | X3C Digital Radiographic DetectorSummary page 4…uct Code: MQB Regulation Number: 21 CFR 892.1680 Device Class: Class II 3. Equivalent legally marketed devices 21 CFR 807.92(a)(3): Predicate device: K070079, X3C Digital Radiographic Detector, IDC Trade Name: X3C Digital Radiographic Detector Model Names: X3C Common Name… | 2007 |
| † | K111098 | Innovaxion FP, Innovaxion FP 1600 Plus, Magellan | 2011 |
| † | K122173 | Digital Flat Planel X-Ray Detector / 1717SCC | 2012 |
| † | K122919 | Digital Flat Panel X-Ray DETECTOR11417PCA | 2013 |
What descends from it? (4)
4 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?
- Its one ancestor has no recall.
- Of its descendants, K181565 (Biokinemetrics, Inc., 2018) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MQB devicesMQB Solid State X-Ray Imager (Flat Panel/Digital Imager): FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · MQB
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQB
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQB
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQB
141in 2025
MAUDE reports naming product code MQB, 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 | 13 | 22 | 15 | 25 |
| 2008 | 8 | 15 | 36 | 30 |
| 2009 | 15 | 57 | 19 | 34 |
| 2010 | 11 | 116 | 14 | 39 |
| 2011 | 24 | 102 | 10 | 101 |
| 2012 | 22 | 80 | 8 | 267 |
| 2013 | 21 | 105 | 6 | 159 |
| 2014 | 32 | 102 | 0 | 29 |
| 2015 | 21 | 81 | 0 | 21 |
| 2016 | 22 | 92 | 0 | 26 |
| 2017 | 31 | 30 | 1 | 20 |
| 2018 | 16 | 30 | 4 | 84 |
| 2019 | 22 | 30 | 1 | 45 |
| 2020 | 19 | 28 | 4 | 9 |
| 2021 | 21 | 48 | 1 | 26 |
| 2022 | 31 | 48 | 0 | 13 |
| 2023 | 10 | 30 | 0 | 51 |
| 2024 | 8 | 187 | 0 | 91 |
| 2025 | 8 | 127 | 1 | 141 |
| 2026 | 3 | 245 | 1 | — |
What is it indicated for?
Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not intended for mammography.
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/K170202 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170202: Aquarius 8600.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170202
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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