510(k) · Cleared
ClearedMedical Image Digitizer, Models CDCR 5020S, UCCR7001 and TCCR 7001
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cr Tech, Ltd. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Sep 21, 2005 after a 107-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Sep 21, 2005
- Review
- 107 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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 CDCR5020s,UCCR7001 and TCCR7001 are intended to be used in radiological practices as laser digitizers for phosphor storage plate. The images are sent for processing to a PC. 1. Model CDCR 5020s This device is used on cassette based x-ray systems using the standard Buckey exist on every system. After exposing the cassette which includes the phosphor plate, the plate is digitized and the digital image is transferred to the PC for processing 2. Models…
Read the full statement (159 words)
The CDCR5020s,UCCR7001 and TCCR7001 are intended to be used in radiological practices as laser digitizers for phosphor storage plate. The images are sent for processing to a PC.
1. Model CDCR 5020s
This device is used on cassette based x-ray systems using the standard Buckey exist on every system.
After exposing the cassette which includes the phosphor plate, the plate is digitized and the digital image is transferred to the PC for processing
2. Models UCCR 7001, TCCR 7001
With these two devices the organ or object for x-ray exposure are positioned in the front of the device (near the phosphor plate which is positioned into the device) and after exposure the digitizing process is taking place, then the Digital image is transferred to the PC for processing.
The only difference in the models are the way of use eather Vertical for Upright or horizontal under the Radiographic Table.
ALL ABOVE MODELS ARE NOT TO BE USED FOR MAMMOGRAPHY
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K051494 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051494: Medical Image Digitizer, Models CDCR 5020S, UCCR7001 and TCCR 7001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051494
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026