510(k) · Cleared
ClearedCR-PRO
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eradlink, Inc. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Nov 17, 2005 as substantially equivalent to K003256 (Orex Computed Radiography, Ltd., 2000) and 1 other predicate after a 28-day review. Its family tree reaches back 4 generations to 1995. 2 later devices descend from it.
- Decided
- Nov 17, 2005
- Review
- 28 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K952914 (1995). 8 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK952914 Star Technologies, Inc. Film Image Scan SystemStar Technologies, Inc. · 1995
- 3 generations backK972191 Digitizer Director (HSC025-01)Howtek, Inc. · 1997
- 2 generations backK980213 DI-2000Lumisys, Inc. · 1998
- 1 generation backK020243 Laserpro 16Eradlink, Inc. · 2002
- This deviceK052938 CR-PROEradlink, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK142718 Radlink GPSRadlink, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK242161 Radlink GPS Pro ImagingRadlink, Inc. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K952914 | Star Technologies, Inc. Film Image Scan System | Star Technologies, Inc. | 1995 | — |
| −3 | K972191 | Digitizer Director (HSC025-01) | Howtek, Inc. | 1997 | — |
| −2 | K980213 | DI-2000 | Lumisys, Inc. | 1998 | — |
| −1 | K020243 | Laserpro 16 | Eradlink, Inc. | 2002 | — |
| 0 (this device) | K052938 | CR-PRO | Eradlink, Inc. | 2005 | — |
| +1 | K142718 | Radlink GPS | Radlink, Inc. | 2014 | — |
| +2 | K242161 | Radlink GPS Pro Imaging | Radlink, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2025 | 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? (2)
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 |
|---|---|---|---|
| * | K003256 | PCCR Digital Imaging DeviceSummary page 1…er regulation 21 CFR 892.1650) (Class II device) PRODUCT CODE: MQB (3) PREDICATE DEVICE: OREX PcCR (K003256) 49 Plain St. Attleboro, MA 02760 (4) DEVICE DES… | 2000 |
| * | K020243 | Laserpro 16Summary page 3…CR-Pro PcCR LS-16 5 100(k) Number -K003256 K020243 Patient Information - Add/Modify/Delete Y Y Y Fax~e ort… | 2002 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142718 | Radlink GPS | 2014 | 1 |
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 10 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K142718 (Radlink, Inc., 2014) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K003256.
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 CR-Pro is a free standing, laser driven, image digitizer intended to produce digital copies of phosphor plate recorded images in 16 levels of gray scale. The digital copies are transmitted to an internal Intel PentiumN 4 based personal computer (PC) where they may be displayed, processed, or compressed for archiving or transmission via computer networks to other medical facility sites.
This device is not to be used for primary imaging diagnosis in mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052938 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052938: CR-PRO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052938
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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