510(k) · Cleared
ClearedEdge Air Digital Flat Panel X-ray Detector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osko, Inc. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Oct 6, 2017 as substantially equivalent to K162519 (Rayence Co., Ltd., 2016) after a 30-day review. Its family tree reaches back 7 generations to 1998. 1 later device descends from it.
- Decided
- Oct 6, 2017
- Review
- 30 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K981556 (1998). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 6 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 5 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 4 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- 3 generations backK090742 Digital Flat Panel X-Ray Detector, Model LTX240AA01-aSamsung Mobile Display Co., Ltd. · 2009
- 2 generations backK150150 1717SGN / 1717SCN Digital Flat Panel X-ray DetectorRayence Co., Ltd. · 2015
- 1 generation backK162519 1717WCC / 1717WGCRayence Co., Ltd. · 2016
- This deviceK172681 Edge Air Digital Flat Panel X-ray DetectorOsko, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK201503 Edge Air (1417) Digital Flat Panel X-ray DetectorOsko, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K201503Edge Air (1417) Digital Flat Panel X-ray DetectorOsko, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −6 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −5 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −4 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| −3 | K090742 | Digital Flat Panel X-Ray Detector, Model LTX240AA01-a | Samsung Mobile Display Co., Ltd. | 2009 | — |
| −2 | K150150 | 1717SGN / 1717SCN Digital Flat Panel X-ray Detector | Rayence Co., Ltd. | 2015 | — |
| −1 | K162519 | 1717WCC / 1717WGC | Rayence Co., Ltd. | 2016 | — |
| 0 (this device) | K172681 | Edge Air Digital Flat Panel X-ray Detector | Osko, Inc. | 2017 | — |
| +1 | K201503 | Edge Air (1417) Digital Flat Panel X-ray Detector | Osko, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 |
|---|---|---|---|
| * | K162519 | 1717WCC / 1717WGCSummary page 4…Class II Predicate Device: Manufacturer: Rayence Co., Ltd. Device: 1717WCC 510(k) Number: K162519 Classification Name: 21CFR892.1680 / Stationary x-ray system Product Code: MQB (Class II) =… | 2016 |
| † | K160579 | Xmaru View V1 and Xmaru PACS, Medical Image Processing Software | 2016 |
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 |
|---|---|---|---|
| K201503 | Edge Air (1417) Digital Flat Panel X-ray Detector | 2020 | 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?
- The line of descent spans 19 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K201503 (Osko, Inc., 2020) 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?
Edge Air Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic system in all general purpose diagnostic procedures. Not to be used for mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172681 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172681: Edge Air Digital Flat Panel X-ray Detector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172681
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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