510(k) · Cleared
ClearedCrystalview T-Series Computed Radiography System, Models T110 (with Eraser) and T100 (Without Eraser)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alara, Inc. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Aug 15, 2007 as substantially equivalent to K042023 (Fujifilm Medical System U.S.A., Inc., 2004) and 1 other predicate after a 57-day review. Its family tree reaches back 2 generations to 1989. 1 later device descends from it.
- Decided
- Aug 15, 2007
- Review
- 57 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K884621 (1989). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK884621 DigiscanSiemens Medical Solutions USA, Inc. · 1989
- 1 generation backK955643 Alara Imaging SystemDenoptix, Inc. · 1996
- This deviceK071682 Crystalview T-Series Computed Radiography System, Models T110 (with…Alara, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK102479 Alara T210 Computed Radiography SystemAlara, Inc. · 2011
Most influential descendants
Showing 1 of 1 · See all- K102479Alara T210 Computed Radiography SystemAlara, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K884621 | Digiscan | Siemens Medical Solutions USA, Inc. | 1989 | — |
| −1 | K955643 | Alara Imaging System | Denoptix, Inc. | 1996 | — |
| 0 (this device) | K071682 | Crystalview T-Series Computed Radiography System, Models T110 (with Eraser)… | Alara, Inc. | 2007 | — |
| +1 | K102479 | Alara T210 Computed Radiography System | Alara, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 3 | 0 |
| 1994 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 |
|---|---|---|---|
| * | K042023 | Fuji Computed Radiography (FCR) Clearview CS Image ReaderSummary page 1…aphy System Common Name: Computed Radiography (CR) System Classification Name: Solid State X-Ray Imager Class I1, 21CFR 892.1650 Product Code: 90-MQB Predicate Device: K042023: Fuji Computed Radiography (FCR) ClearView CS Image Reader (CR-IR363) K955643: DenOptix ALARA Imaging System Product Descriptio… | 2004 |
| * | K955643 | Alara Imaging SystemSummary page 1…Solid State X-Ray Imager Class I1, 21CFR 892.1650 Product Code: 90-MQB Predicate Device: K042023: Fuji Computed Radiography (FCR) ClearView CS Image Reader (CR-IR363) K955643: DenOptix ALARA Imaging System Product Description: The CRystalView T-Series System is an electrostatic X-ray imaging system th… | 1996 |
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 |
|---|---|---|---|
| K102479 | Alara T210 Computed Radiography System | 2011 | 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 18 years and passes through 3 companies; a new generation was cleared every 11.5 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K102479 (Alara, Inc., 2011) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K042023.
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. 2007, 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 CRystalView T-Series is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in general-purpose diagnostic procedures.
The CRystalView T-Series is not indicated for use in mammography.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K071682 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071682: Crystalview T-Series Computed Radiography System, Models T110 (with Eraser) and T100 (Without Eraser).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071682
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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