510(k) · Cleared
ClearedVita Flex CR System with LLI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carestream Health, Inc. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Feb 18, 2020 as substantially equivalent to K073670 (Orex Computed Radiography, Ltd., 2008) after a 130-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Feb 18, 2020
- Review
- 130 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K960834 (1996). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK960834 Kodak EC-L CassetteEastman Kodak Company · 1996
- 2 generations backK032654 Port CassetteOrex Computed Radiography, Ltd. · 2003
- 1 generation backK073670 Kodak Point of Care CR 120, Kodak Point of Care CR 140, Kodak Point…Orex Computed Radiography, Ltd. · 2008
- This deviceK192894 Vita Flex CR System with LLICarestream Health, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K960834 | Kodak EC-L Cassette | Eastman Kodak Company | 1996 | — |
| −2 | K032654 | Port Cassette | Orex Computed Radiography, Ltd. | 2003 | — |
| −1 | K073670 | Kodak Point of Care CR 120, Kodak Point of Care CR 140, Kodak Point of Care CR… | Orex Computed Radiography, Ltd. | 2008 | — |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K073670 | Kodak Point of Care CR 120, Kodak Point of Care CR 140, Kodak Point of Care CR 260Summary page 4…Point of care including LLI Manufactured by: Carestream Health, Inc. Systems 510(k) No.: K073670 (01/25/2008) Predicate Device Class: 2 Predicate Device Code: MQB Regulation Number: 21… | 2008 |
| † | K100094 | Carestream Image Suite | 2010 |
| † | K021829 | Modification to Kodak Directview CR 800/900 System | 2002 |
| † | K130567 | DR Long Length Imaging Software | 2013 |
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 24 years and passes through 3 companies; a new generation was cleared every 7.4 years on median.
- None of the 5 ancestors has a 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. 2020, 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 Vita Flex CR System 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/K192894 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192894: Vita Flex CR System with LLI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192894
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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