510(k) · Cleared
ClearedAquarius 8600 Digital Radiography Sensor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biokinemetrics, Inc. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Jul 13, 2018 as substantially equivalent to K170202 (Imaging Dynamics Company, Ltd., 2017) and 1 other predicate after a 29-day review. Its family tree reaches back 2 generations to 2006.
- Decided
- Jul 13, 2018
- Review
- 29 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K063247 (2006). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK063247 Xplorer 1800 Digital Radiographic System with Universal StandImaging Dynamics Company, Ltd. · 2006
- 1 generation backK092307 Imasight 4600 Digital Radiography SensorImasight, Inc. · 2009
- This deviceK181565 Aquarius 8600 Digital Radiography SensorBiokinemetrics, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K063247 | Xplorer 1800 Digital Radiographic System with Universal Stand | Imaging Dynamics Company, Ltd. | 2006 | — |
| −1 | K092307 | Imasight 4600 Digital Radiography Sensor | Imasight, Inc. | 2009 | — |
| 0 (this device) | K181565 | Aquarius 8600 Digital Radiography Sensor | Biokinemetrics, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2017 | 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? (2)
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 |
|---|---|---|---|
| * | K170202 | Aquarius 8600Summary page 4…tware modifications to support Aquarius 8600 Flat Panel Detector. 6. Predicate devices: Primary: Aquarius 8600 Flat Panel Detector (K170202) For the ChiroSight software: BIOK4600 Digital Radiography Senso… | 2017 |
| * | K092307 | Imasight 4600 Digital Radiography SensorSummary page 4…ius 8600 Flat Panel Detector (K170202) For the ChiroSight software: BIOK4600 Digital Radiography Sensor (K092307) *same classification & product code: 21 CFR 892.1680, 90/MQB, KPR… | 2009 |
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 12 years and passes through 3 companies; a new generation was cleared every 8.9 years on median.
- None of the 4 ancestors has a recall.
- 3 other devices also cite its predicate K170202.
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. 2018, 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?
The AQUARIUS 8600 is intended for use by a qualified doctor or technologist on both adult and paediatric patients for taking diagnostic radiographic exposures of all body parts of the patients. The AQUARIUS 8600 provides digital image capture and is intended to replace radiographic film/screen. The x-ray generator, x-ray tube and associated equipment are not provided with the proposed sensor. Prescription use only.
The AQUARIUS 8600 is 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/K181565 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181565: Aquarius 8600 Digital Radiography Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181565
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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