510(k) · Cleared
ClearedKodak Point of Care CR 120, Kodak Point of Care CR 140, Kodak Point of Care CR 260
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 Jan 25, 2008 as substantially equivalent to K003256 (Orex Computed Radiography, Ltd., 2000) and 2 other predicates after a 29-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it.
- Decided
- Jan 25, 2008
- Review
- 29 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K960834 (1996). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK960834 Kodak EC-L CassetteEastman Kodak Company · 1996
- 1 generation backK032654 Port CassetteOrex Computed Radiography, Ltd. · 2003
- This deviceK073670 Kodak Point of Care CR 120, Kodak Point of Care CR 140, Kodak Point…Orex Computed Radiography, Ltd. · 2008
- Descendant · cites it directly · 0 of its ownK192894 Vita Flex CR System with LLICarestream Health, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K192894Vita Flex CR System with LLICarestream Health, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K960834 | Kodak EC-L Cassette | Eastman Kodak Company | 1996 | — |
| −1 | K032654 | Port Cassette | Orex Computed Radiography, Ltd. | 2003 | — |
| 0 (this device) | K073670 | Kodak Point of Care CR 120, Kodak Point of Care CR 140, Kodak Point of Care CR… | Orex Computed Radiography, Ltd. | 2008 | — |
| +1 | K192894 | Vita Flex CR System with LLI | Carestream Health, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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? (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 |
|---|---|---|---|
| * | K003256 | PCCR Digital Imaging DeviceSummary page 1…ology Reason for 510(k) Submission Special 510(k) Submission Identification of Legally Marketed predicate Devices 1. Orex unmodified predicate device: (K003256) PcCR DIGITAL IMAGING, including the (K032654) PORT CASSETTE ii Kodak unmodified predicate device: (K0… | 2000 |
| * | K032654 | Port CassetteSummary page 1…ssion Identification of Legally Marketed predicate Devices 1. Orex unmodified predicate device: (K003256) PcCR DIGITAL IMAGING, including the (K032654) PORT CASSETTE ii Kodak unmodified predicate device: (K021 829) Kodak DirectView CR Long Length Device… | 2003 |
| * | K021829 | Modification to Kodak Directview CR 800/900 SystemSummary page 1…Orex unmodified predicate device: (K003256) PcCR DIGITAL IMAGING, including the (K032654) PORT CASSETTE ii Kodak unmodified predicate device: (K021 829) Kodak DirectView CR Long Length Device Description Point of care including LUI is a Computer Radiography (CR) acq… | 2002 |
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 |
|---|---|---|---|
| K192894 | Vita Flex CR System with LLI | 2020 | 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?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 7.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K192894 (Carestream Health, Inc., 2020) has gone furthest, with 0 descendants 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. 2008, this device’s year, is highlighted.
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 Point-of-Care is intended for digital radiography using a phosphor storage screen for standard radiographic diagnostic images.
The LLI is indicated for Long Length Imaging examinations of long areas of anatomy such as the leg and spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073670 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073670: Kodak Point of Care CR 120, Kodak Point of Care CR 140, Kodak Point of Care CR 260.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073670
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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