510(k) · Cleared
ClearedPCCR Digital Imaging Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orex Computed Radiography, Ltd. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Nov 8, 2000 after a 22-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Nov 8, 2000
- Review
- 22 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK003256 PCCR Digital Imaging DeviceOrex Computed Radiography, Ltd. · 2000
- Descendant · cites it directly · 2 of its ownK052938 CR-PROEradlink, Inc. · 2005
- Descendant · 2 generations on · 1 of its ownK142718 Radlink GPSRadlink, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK073670 Kodak Point of Care CR 120, Kodak Point of Care CR 140, Kodak Point…Orex Computed Radiography, Ltd. · 2008
- Descendant · 3 generations on · 0 of its ownK242161 Radlink GPS Pro ImagingRadlink, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK192894 Vita Flex CR System with LLICarestream Health, Inc. · 2020
Most influential descendants
Showing 5 of 5 · See all- K052938CR-PROEradlink, Inc. · 2005 · cites it directly2descendants
- K142718Radlink GPSRadlink, Inc. · 2014 · 2 generations on1descendant
- K073670Kodak Point of Care CR 120, Kodak Point of Care CR 140, Kodak Point of Care CR 260Orex Computed Radiography, Ltd. · 2008 · cites it directly1descendant
- K242161Radlink GPS Pro ImagingRadlink, Inc. · 2025 · 3 generations on0descendants
- K192894Vita Flex CR System with LLICarestream Health, Inc. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003256 | PCCR Digital Imaging Device | Orex Computed Radiography, Ltd. | 2000 | — |
| +1 | K052938 | CR-PRO | Eradlink, Inc. | 2005 | — |
| +2 | K142718 | Radlink GPS | Radlink, Inc. | 2014 | — |
| +1 | K073670 | Kodak Point of Care CR 120, Kodak Point of Care CR 140, Kodak Point of Care CR… | Orex Computed Radiography, Ltd. | 2008 | — |
| +3 | K242161 | Radlink GPS Pro Imaging | Radlink, Inc. | 2025 | — |
| +2 | K192894 | Vita Flex CR System with LLI | Carestream Health, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2014 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K052938 (Eradlink, Inc., 2005) has gone furthest, with 2 descendants of its own.
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 | — |
https://510kreport.com/device/K003256 · printed Nov 3, 2026
Cite this page
510(k) Report. “K003256: PCCR Digital Imaging Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K003256
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026