510(k) · Cleared
ClearedOldelft Digidelca
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oldelft Corp. of America · KPR System, X-Ray, Stationary
Cleared on Apr 17, 1998 as substantially equivalent to K892659 (Oldelft Corp. of America, 1989) and 2 other predicates after an 80-day review. Its family tree reaches back 1 generation to 1989. 1 later device descends from it.
- Decided
- Apr 17, 1998
- Review
- 80 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K892659 (1989). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K012165Oldelft Thorascan Model Number 180TNucletron Corp. · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K892659 | Electrodelca | Oldelft Corp. of America | 1989 | — |
| 0 (this device) | K980296 | Oldelft Digidelca | Oldelft Corp. of America | 1998 | — |
| +1 | K012165 | Oldelft Thorascan Model Number 180T | Nucletron Corp. | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 KPR? 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 KPR device
- #1 K242119 Innovision-Exiiscore 17.0 · 9 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 |
|---|---|---|---|
| * | K892659 | ElectrodelcaSummary page 2…electrical, mechanical and optical system layout and to AMBER-DU and HyperPACS for the software configuration: e The Oldelft Electrodelca (tm) mass chest x-ray system (K892659) for the camera housing basic design, the image intensifier tube, the elevator stand basic design and the compatible x-ray tube a… | 1989 |
| * | K950343 | Hyperpacs Pacs and Telerafiology SystemSummary page 2…gh voltage generator selection. The image capturing device in Digidelca is a TD!I CCD sensor, instead of radiographic film. ® The Rogan HyperPACS (tm) software package (K950343) for the principal software tasks for the Operators Workstation: image acquisition and storage, image export, network interfacing… | 1995 |
| * | K973219 | Amber DUSummary page 2…kage (K950343) for the principal software tasks for the Operators Workstation: image acquisition and storage, image export, network interfacing. ® The Oldelft Amber-DU (K973219) software package (reconfigured) for user interfacing at the Operators Workstation. The Operators Workstation displays screens t… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012165 | Oldelft Thorascan Model Number 180T | 2001 | 0 |
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?
- None of the 3 ancestors has a recall.
- Of its descendants, K012165 (Nucletron Corp., 2001) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KPR
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPR
155in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPR
7in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KPR
39in 2025
MAUDE reports naming product code KPR, 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 | 12 | 31 | 10 | 120 |
| 2008 | 15 | 48 | 10 | 95 |
| 2009 | 9 | 35 | 5 | 61 |
| 2010 | 9 | 126 | 3 | 82 |
| 2011 | 9 | 152 | 5 | 103 |
| 2012 | 11 | 58 | 1 | 74 |
| 2013 | 5 | 163 | 5 | 24 |
| 2014 | 10 | 108 | 8 | 34 |
| 2015 | 18 | 81 | 1 | 59 |
| 2016 | 11 | 84 | 4 | 18 |
| 2017 | 6 | 75 | 3 | 31 |
| 2018 | 15 | 30 | 4 | 36 |
| 2019 | 12 | 33 | 1 | 77 |
| 2020 | 16 | 39 | 1 | 41 |
| 2021 | 6 | 55 | 0 | 37 |
| 2022 | 8 | 43 | 2 | 27 |
| 2023 | 9 | 76 | 4 | 39 |
| 2024 | 11 | 162 | 1 | 34 |
| 2025 | 8 | 155 | 7 | 39 |
| 2026 | 6 | 197 | 0 | — |
What is it indicated for?
Digidelca provides the radiologists or pneumologists the ability to acquire chest x-ray images by filmless radiography (digital radiography), based on CCD technology. The x-ray transmission profile of the chest is converted into an electronic, digital image in real-time. Chest images become available for preview by the x-ray technician on the operators workstation only seconds after the x-ray exposure. After acceptance by the tech, digital (DICOM) images…
Read the full statement (127 words)
Digidelca provides the radiologists or pneumologists the ability to acquire chest x-ray images by filmless radiography (digital radiography), based on CCD technology. The x-ray transmission profile of the chest is converted into an electronic, digital image in real-time. Chest images become available for preview by the x-ray technician on the operators workstation only seconds after the x-ray exposure. After acceptance by the tech, digital (DICOM) images can be stored on electronic media, as e.g. CD-ROM, magnetic disk, or be exported to a (DICOM/PACS) network, c.g. clinical review station or to a film printer.
Note: PACS, networks, clinical review stations and (laser-) film printers are not considered part of the Digidelca system for which this application is filed, only external interfacs to this type of equipment are defined.
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/K980296 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980296: Oldelft Digidelca.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980296
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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