510(k) · Cleared
ClearedXplorer 1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imaging Dynamics Corp. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Jun 2, 2000 as substantially equivalent to K974863 (Advanced Instrument Development, Inc., 1998) after a 275-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it.
- Decided
- Jun 2, 2000
- Review
- 275 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K974863 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK974863 Imix Digital Thorax SystemAdvanced Instrument Development, Inc. · 1998
- This deviceK992955 Xplorer 1000Imaging Dynamics Corp. · 2000
- Descendant · cites it directly · 0 of its ownK093816 Digital Radiography System, Models Galaxy 900 and 1600Medien International Co, Ltd. · 2010
Most influential descendants
Showing 1 of 1 · See all- K093816Digital Radiography System, Models Galaxy 900 and 1600Medien International Co, Ltd. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K974863 | Imix Digital Thorax System | Advanced Instrument Development, Inc. | 1998 | — |
| 0 (this device) | K992955 | Xplorer 1000 | Imaging Dynamics Corp. | 2000 | — |
| +1 | K093816 | Digital Radiography System, Models Galaxy 900 and 1600 | Medien International Co, Ltd. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 |
|---|---|---|---|
| * | K974863 | Imix Digital Thorax SystemSummary page 1…er Classification name Solid State X-ray Imager Identification of predicate device(s) Page 10 K192455 frge 1= Equivalency is based on the IMIX DIGITAL THORAX SYSTEM (K974863) and conventional radiographic film (21 CFR 892.1840). Description of the device The Xplorer 1000 is an optical based digital… | 1998 |
| * | — | conventional radiographic film Named without a submission number |
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 |
|---|---|---|---|
| K093816 | Digital Radiography System, Models Galaxy 900 and 1600 | 2010 | 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?
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.
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 in general human radiography imaging similar to the optically coupled CCD based device cleared under 510(k) number K974863.
Not to be used 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/K992955 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992955: Xplorer 1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992955
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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