510(k) · Cleared
ClearedOldelft Thorascan Model Number 180T
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nucletron Corp. · KPR System, X-Ray, Stationary
Cleared on Sep 19, 2001 as substantially equivalent to K980296 (Oldelft Corp. of America, 1998) after a 70-day review. Its family tree reaches back 2 generations to 1989.
- Decided
- Sep 19, 2001
- Review
- 70 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K892659 (1989). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K892659 | Electrodelca | Oldelft Corp. of America | 1989 | — |
| −1 | K980296 | Oldelft Digidelca | Oldelft Corp. of America | 1998 | — |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K980296 | Oldelft DigidelcaSummary page 1…ur device is substantially equivalent to the legally marketed predicate device cited in the table below: ~ Device . 510(k) # Manufacturer [ Nucletron BV | Digidelca 'K980296 d. Description: ThoraScan is a digital X-ray chest camera based on slot-scan technology and is designed to perform radiographi… | 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 12 years and passes through 2 companies; a new generation was cleared every 8.4 years on median.
- None of the 4 ancestors has a recall.
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?
ThoraScan provides the radiologists or pneumologists the ability to acquire chest x-ray images by filmless radiography (digital radiography), based on a Csl/CCD slot scan detector produced by Thomson TE. 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 operator's workstation only seconds after the x-ray exposure. After…
Read the full statement (134 words)
ThoraScan provides the radiologists or pneumologists the ability to acquire chest x-ray images by filmless radiography (digital radiography), based on a Csl/CCD slot scan detector produced by Thomson TE.
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 operator's 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.q. 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 interfaces tot 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/K012165 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012165: Oldelft Thorascan Model Number 180T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012165
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026