510(k) · Cleared
ClearedNDR+/Diva-D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nical Spa · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Jan 6, 2006 as substantially equivalent to K012490 (Infimed, Inc., 2002) after a 71-day review. Its family tree reaches back 2 generations to 1991. 3 later devices descend from it.
- Decided
- Jan 6, 2006
- Review
- 71 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K911454 (1991). 3 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK911454 FC2000S & S Inficon, Inc. · 1991
- 1 generation backK012490 Orion Digital Imaging SystemInfimed, Inc. · 2002
- This deviceK053029 NDR+/Diva-DNical Spa · 2006
- Descendant · cites it directly · 2 of its ownK080859 DRF 4343Villa Sistemi Medicali S.P.A. · 2008
- Descendant · 2 generations on · 1 of its ownK103038 Duet DRFCmt Medical Technologies, Ltd. · 2011
- Descendant · 3 generations on · 0 of its ownK202235 ArtPIX DRFCmt Medical Technologies, Ltd. · 2020
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K911454 | FC2000 | S & S Inficon, Inc. | 1991 | — |
| −1 | K012490 | Orion Digital Imaging System | Infimed, Inc. | 2002 | — |
| 0 (this device) | K053029 | NDR+/Diva-D | Nical Spa | 2006 | — |
| +1 | K080859 | DRF 4343 | Villa Sistemi Medicali S.P.A. | 2008 | — |
| +2 | K103038 | Duet DRF | Cmt Medical Technologies, Ltd. | 2011 | — |
| +3 | K202235 | ArtPIX DRF | Cmt Medical Technologies, Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K012490 | Orion Digital Imaging SystemSummary page 1…valent device: the NDR+/DIVA-D is defined as Substantially Equivalent (SE) to the INFIMED Platinum ONE digital image acquisition system (certified under the name ORION) (K012490). The following table compares the NDR+/DIVA-D and the predicate device FEATURES NICAL (NDR+/DIVA D) INFIMED (… | 2002 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080859 | DRF 4343 | 2008 | 2 |
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 15 years and passes through 3 companies; a new generation was cleared every 10.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K080859 (Villa Sistemi Medicali S.P.A., 2008) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K012490.
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?
The indication for use of the NDR+/DIVA-D is: DIGITAL IMAGE ACQUISITION SYSTEM TO BE USED IN CONJUCTION WITH AN IMAGE INTESIFIER DURING RADIOGRAPHY OR FLUOROSCOPY X-RAY EXAMINATION TO CAPTURE IMAGES BY A CAMERA, DIGITALIZE THE IMAGE, REVIEW IMAGES AND FORMAT IMAGES ACCORDING TO DICOM PROTOCOL TO BE SENT THROUGH NETWORK CONNECTION
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/K053029 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053029: NDR+/Diva-D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053029
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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