510(k) · Cleared
ClearedEOS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eos Imaging · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Apr 6, 2012 as substantially equivalent to K071546 (Biospace Med, 2007) after a 29-day review. Its family tree reaches back 4 generations to 1981. 6 later devices descend from it.
- Decided
- Apr 6, 2012
- Review
- 29 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K803130 (1981). 15 ancestors in all, the oldest K790692 (1979). 6 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
- 3 generations backK971452 Multix Top/Pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc. · 1997 · Recalled
- 2 generations backK983732 Thorax FD and Multix FDSiemens Medical Solutions USA, Inc. · 1999 · Recalled
- 1 generation backK071546 EOSBiospace Med · 2007 · Recalled
- This deviceK120721 EOSEos Imaging · 2012
- Descendant · cites it directly · 5 of its ownK123740 EOSEos Imaging · 2013 · Recalled
- Descendant · 2 generations on · 4 of its ownK142773 EOS SystemEos Imaging · 2015
- Descendant · 3 generations on · 3 of its ownK152788 EOS SystemEos Imaging · 2015
- Descendant · 4 generations on · 2 of its ownK192079 EOSedgeEos Imaging · 2019
- Descendant · 5 generations on · 1 of its ownK202394 EOSedgeEos Imaging · 2020 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K123740EOSEos Imaging · 2013 · cites it directly5descendants
- K142773EOS SystemEos Imaging · 2015 · 2 generations on4descendants
- K152788EOS SystemEos Imaging · 2015 · 3 generations on3descendants
- K192079EOSedgeEos Imaging · 2019 · 4 generations on2descendants
- K202394EOSedgeEos Imaging · 2020 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K803130 | Multix U. Bucky Table X-Ray Unit | Siemens Corp. | 1981 | 1 |
| −3 | K971452 | Multix Top/Pro Radiographic X-Ray Table | Siemens Medical Solutions USA, Inc. | 1997 | 8 |
| −2 | K983732 | Thorax FD and Multix FD | Siemens Medical Solutions USA, Inc. | 1999 | 1 |
| −1 | K071546 | EOS | Biospace Med | 2007 | 1 |
| 0 (this device) | K120721 | EOS | Eos Imaging | 2012 | — |
| +1 | K123740 | EOS | Eos Imaging | 2013 | 1 |
| +2 | K142773 | EOS System | Eos Imaging | 2015 | — |
| +3 | K152788 | EOS System | Eos Imaging | 2015 | — |
| +4 | K192079 | EOSedge | Eos Imaging | 2019 | — |
| +5 | K202394 | EOSedge | Eos Imaging | 2020 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1984 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K071546 | EOSSummary page 1…NCE Common or Usual Name: Digital Radiography System Classification Name: Radiology Predicate Devices: EQS imaging's EQS (K071 546) Purpose of the Special 51 0(k) notice. The modified EQS is a modification to the cleared EQS. Intended Use The EQS is inten… | 2007 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123740 | EOS | 2013 | 5 |
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 31 years and passes through 4 companies; a new generation was cleared every 8.4 years on median.
- 8 of the 15 ancestors have a recall of any class.
- Of its descendants, K123740 (Eos Imaging, 2013) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K071546.
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. 2012, 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 EQS is intended for use in general radiographic examinations and applications, excluding the evaluation of lung nodules and examinations involving fluoroscopy, angiography and mammography.
EQS allows the radiographic acquisition of either one or two orthogonal X ray images for diagnostic purposes, in one single scan, of the whole body or a reduced area of investigation of a patient in the upright or seated position.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120721 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120721: EOS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120721
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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