510(k) · Cleared
Recalled · Class II · 2018Nova FA DR System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sedecal., Sa. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Mar 21, 2014 as substantially equivalent to K090279 (Sedecal., Sa., 2009) after a 99-day review. Its family tree reaches back 6 generations to 1998. 11 later devices descend from it. It has been recalled once.
- Decided
- Mar 21, 2014
- Review
- 99 days
- Class
- Class II
- Product code
- MQB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to K981556 (1998). 10 ancestors in all. 11 later devices descend from it, 5 citing it directly.
- 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 backK042876 Urs LP Digital, Millennium, RadproSedecal., Sa. · 2004
- 1 generation backK090279 Sedecal, Millennium PlusSedecal., Sa. · 2009
- This deviceK133782 Nova FA DR SystemSedecal., Sa. · 2014
- Descendant · cites it directly · 2 of its ownK173953 uDR 780iShanghai United Imaging Healthcare Co., Ltd. · 2018
- Descendant · cites it directly · 2 of its ownK150816 Jumong SeriesSg Healthcare Co, Ltd. · 2015
- Descendant · cites it directly · 2 of its ownK143257 KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic…Medicatech USA · 2015
- Descendant · 2 generations on · 1 of its ownK241068 uDR 780iShanghai United Imaging Healthcare Co., Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK251167 uDR Aurora CXShanghai United Imaging Healthcare Co., Ltd. · 2025
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K173953uDR 780iShanghai United Imaging Healthcare Co., Ltd. · 2018 · cites it directly2descendants
- K150816Jumong SeriesSg Healthcare Co, Ltd. · 2015 · cites it directly2descendants
- K143257KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic SystemMedicatech USA · 2015 · cites it directly2descendants
- K241068uDR 780iShanghai United Imaging Healthcare Co., Ltd. · 2024 · 2 generations on1descendant
- K251167uDR Aurora CXShanghai United Imaging Healthcare Co., Ltd. · 2025 · 3 generations on0descendants
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 | K042876 | Urs LP Digital, Millennium, Radpro | Sedecal., Sa. | 2004 | — |
| −1 | K090279 | Sedecal, Millennium Plus | Sedecal., Sa. | 2009 | — |
| 0 (this device) | K133782 | Nova FA DR System | Sedecal., Sa. | 2014 | — |
| +1 | K173953 | uDR 780i | Shanghai United Imaging Healthcare Co., Ltd. | 2018 | — |
| +1 | K150816 | Jumong Series | Sg Healthcare Co, Ltd. | 2015 | — |
| +1 | K143257 | KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic System | Medicatech USA | 2015 | — |
| +2 | K241068 | uDR 780i | Shanghai United Imaging Healthcare Co., Ltd. | 2024 | — |
| +3 | K251167 | uDR Aurora CX | Shanghai United Imaging Healthcare Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K090279 | Sedecal, Millennium PlusSummary page 1…ary X-Ray System, Product Codes MQB and KPIR Common/Usual Name: Digital Diagnostic X-Ray System; Regulation 21 CFR892.1680 3. Equivalent legally marketed device: K090279, Sedlecal Millennium Plus Digital Diagnostic X-Ray Systems. 4. Description of the Device: 'NOVA FA DR System" refers to a full… | 2009 |
| † | K103591 | Digital Radiography | 2011 |
| † | K091436 | Digital Radiography, Model Cxdi-55C | 2009 |
| † | K111682 | Digital Radiography | 2011 |
What descends from it? (11)
See all 115 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 18, 2018 | Class II | Z-0488-2019 | Device Design | A safety problem with installation and maintenance could lead to the breakage of the two steel cables that support the equipment to its roof anchor. Due to this, the equipment may fall and cause harm to the patient, user, or third parties. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K173953 (Shanghai United Imaging Healthcare Co., Ltd., 2018) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K090279.
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. 2014, 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?
Sedlecal "NOVA FA DR System" is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest. abdomen, extremities, and other body pants. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133782 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133782: Nova FA DR System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133782
Report an extraction error
Are you the manufacturer?
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