510(k) · Cleared
ClearedImasight 4600 Digital Radiography Sensor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imasight, Inc. · KPR System, X-Ray, Stationary
Cleared on Aug 25, 2009 as substantially equivalent to K063247 (Imaging Dynamics Company, Ltd., 2006) after a 26-day review. Its family tree reaches back 1 generation to 2006. 1 later device descends from it.
- Decided
- Aug 25, 2009
- Review
- 26 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K063247 (2006). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK063247 Xplorer 1800 Digital Radiographic System with Universal StandImaging Dynamics Company, Ltd. · 2006
- This deviceK092307 Imasight 4600 Digital Radiography SensorImasight, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK181565 Aquarius 8600 Digital Radiography SensorBiokinemetrics, Inc. · 2018
Most influential descendants
Showing 1 of 1 · See all- K181565Aquarius 8600 Digital Radiography SensorBiokinemetrics, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K063247 | Xplorer 1800 Digital Radiographic System with Universal Stand | Imaging Dynamics Company, Ltd. | 2006 | — |
| 0 (this device) | K092307 | Imasight 4600 Digital Radiography Sensor | Imasight, Inc. | 2009 | — |
| +1 | K181565 | Aquarius 8600 Digital Radiography Sensor | Biokinemetrics, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K063247 | Xplorer 1800 Digital Radiographic System with Universal StandSummary page 1…II, 892.1680 (KPR) 5. Product Code: 9OMQB 6. Basis for the submission: New device 7. Predicate device: Xplorer 1800 Digital Radiographic System (K063247) 8. Device description: The ImaSight 4600 is a digital radiographic sensor which automatically collects x-ray images f… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181565 | Aquarius 8600 Digital Radiography Sensor | 2018 | 0 |
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 KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 ImaSight 4600 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 ImaSight 4600 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. The ImaSight 4600 is not intended for mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092307 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092307: Imasight 4600 Digital Radiography Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092307
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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