510(k) · Cleared
ClearedTelevere Digital Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Televere Systems · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on May 1, 2017 as substantially equivalent to K123644 (Viztek, LLC, 2013) after a 28-day review. Its family tree reaches back 9 generations to 1998. 2 later devices descend from it.
- Decided
- May 1, 2017
- Review
- 28 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K981556 (1998). 20 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 5 generations between
- 3 generations backK102123 Vizion DRViztek, Inc. · 2011
- 2 generations backK112661 Vizion DRViztek, LLC · 2011
- 1 generation backK123644 Vizion + DRViztek, LLC · 2013
- This deviceK170975 Televere Digital Imaging SystemTelevere Systems · 2017
- Descendant · cites it directly · 0 of its ownK180765 Televere Podiatry X-Ray System HFTelevere Systems, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK172124 Televere Podiatry Digital Imaging SystemTelevere Systems · 2017
Show all 9 generations
- Root · 9 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 8 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 7 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 6 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- 5 generations backK042876 Urs LP Digital, Millennium, RadproSedecal., Sa. · 2004
- 4 generations backK082604 Viztek DR, Models: DR1000, DR3000, DR4000Viztek, Inc. · 2008
- 3 generations backK102123 Vizion DRViztek, Inc. · 2011
- 2 generations backK112661 Vizion DRViztek, LLC · 2011
- 1 generation backK123644 Vizion + DRViztek, LLC · 2013
- This deviceK170975 Televere Digital Imaging SystemTelevere Systems · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −8 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −7 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −6 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| −5 | K042876 | Urs LP Digital, Millennium, Radpro | Sedecal., Sa. | 2004 | — |
| −4 | K082604 | Viztek DR, Models: DR1000, DR3000, DR4000 | Viztek, Inc. | 2008 | — |
| −3 | K102123 | Vizion DR | Viztek, Inc. | 2011 | — |
| −2 | K112661 | Vizion DR | Viztek, LLC | 2011 | — |
| −1 | K123644 | Vizion + DR | Viztek, LLC | 2013 | — |
| 0 (this device) | K170975 | Televere Digital Imaging System | Televere Systems | 2017 | — |
| +1 | K180765 | Televere Podiatry X-Ray System HF | Televere Systems, Inc. | 2018 | — |
| +1 | K172124 | Televere Podiatry Digital Imaging System | Televere Systems | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 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 |
|---|---|---|---|
| * | K123644 | Vizion + DRSummary page 4…anel Device Class/Regulation Number: Class II per regulation 892.1680 2. Equivalent legally marketed device: ViZion + DR, Digital Flat Panel X-Ray Detector System K123644 Classification Name: Stationary X-ray System Product Code MQB, Common/Usual Name: Digital X-Ray Receptor Panel Device… | 2013 |
What descends from it? (2)
2 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?
- The line of descent spans 19 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 20 ancestors has a recall of any class.
- Of its descendants, K180765 (Televere Systems, Inc., 2018) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K123644.
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?
The Televere Digital Imaging System is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used. Allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities. Not for mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170975 · printed Nov 5, 2026
Cite this page
510(k) Report. “K170975: Televere Digital Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K170975
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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