510(k) · Cleared
ClearedSanteview
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sehyun Co., Ltd. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Jul 13, 2011 as substantially equivalent to K024147 (Varian Medical Systems, Inc., 2003) and 2 other predicates after a 64-day review. Its family tree reaches back 6 generations to 1998.
- Decided
- Jul 13, 2011
- Review
- 64 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K981556 (1998). 25 ancestors in all, the oldest K803130 (1981). No later device cites it as a predicate yet.
- Root · 6 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 5 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 4 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 3 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- 2 generations backK060433 Digital Radiography Cxdi-50CCanon, Inc. · 2006
- 1 generation backK091545 Digital Radiography Cxdi-60CCanon, Inc. · 2009
- This deviceK111312 SanteviewSehyun Co., Ltd. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −5 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −4 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −3 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| −2 | K060433 | Digital Radiography Cxdi-50C | Canon, Inc. | 2006 | — |
| −1 | K091545 | Digital Radiography Cxdi-60C | Canon, Inc. | 2009 | — |
| 0 (this device) | K111312 | Santeview | Sehyun Co., Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2008 | 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? (3)
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 |
|---|---|---|---|
| * | K024147 | Paxscan 4030 Medical Digital Imaging SystemSummary page 1…tion regulation: 21 CER 892.1650 "Product Code: MQB 4. Predicate Device: -PaxScan 4030 Medical Digital Imaging System by Varian Medic al System (K024 147) .CXDI-60C by Canon USA, lnc.(K09 1545) *Pixium 4600 (cleared under the name, Philips Bucky Vision) by Trixell… | 2003 |
| * | K091545 | Digital Radiography Cxdi-60CSummary page 1…ct Code: MQB 4. Predicate Device: -PaxScan 4030 Medical Digital Imaging System by Varian Medic al System (K024 147) .CXDI-60C by Canon USA, lnc.(K09 1545) *Pixium 4600 (cleared under the name, Philips Bucky Vision) by Trixell (K982795) 5. Description: The Sa… | 2009 |
| * | K982795 | Philips Bucky VisionSummary page 1…tem by Varian Medic al System (K024 147) .CXDI-60C by Canon USA, lnc.(K09 1545) *Pixium 4600 (cleared under the name, Philips Bucky Vision) by Trixell (K982795) 5. Description: The SanteView-3001 C is a solid state x-ray imager which has 440x440mm 510(k) Submission.… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
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 13 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 10 of the 25 ancestors have a recall of any class.
- 5 other devices also cite its predicate K024147.
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. 2011, 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 Sante View-3001C provides digital image capture for conventional film/screen radiographic examinations. The device is intended to replace radiographic filmn/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111312 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111312: Santeview.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111312
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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