510(k) · Cleared
ClearedAlara Crystalview Computed Radiography System, Model R200
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 Jun 30, 2006 as substantially equivalent to K032210 (Alara, Inc., 2003) and 1 other predicate after a 28-day review. Its family tree reaches back 3 generations to 1991. 1 later device descends from it.
- Decided
- Jun 30, 2006
- Review
- 28 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K904519 (1991). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK904519 Agfa Diagnostic Center (Adc)Enhanced Imaging Technologies, Inc. · 1991
- 2 generations backK974597 Adc Compact (Agfa Diagnostic Center)Bayer Corp., Agfa Div. · 1998 · Recalled
- 1 generation backK032210 Alara Crystalview Computed Radiography SystemAlara, Inc. · 2003
- This deviceK061538 Alara Crystalview Computed Radiography System, Model R200Alara, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK062390 Crystalview R200Alara, Inc. · 2006
Most influential descendants
Showing 1 of 1 · See all- K062390Crystalview R200Alara, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K904519 | Agfa Diagnostic Center (Adc) | Enhanced Imaging Technologies, Inc. | 1991 | — |
| −2 | K974597 | Adc Compact (Agfa Diagnostic Center) | Bayer Corp., Agfa Div. | 1998 | 1 |
| −1 | K032210 | Alara Crystalview Computed Radiography System | Alara, Inc. | 2003 | — |
| 0 (this device) | K061538 | Alara Crystalview Computed Radiography System, Model R200 | Alara, Inc. | 2006 | — |
| +1 | K062390 | Crystalview R200 | Alara, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 |
|---|---|---|---|
| * | K032210 | Alara Crystalview Computed Radiography SystemSummary page 1…Name: Computed Radiography (CR) System Classification Name: Solid State X-Ray Imager (per 21 CFR 892.1650) Predicate Devices: ~ Alara CRystalView CR System S10(k)y# KO032210 Agfa ADC Compact K974597 Product Description: The Alara CRystalView® R200 is a desktop Computed Radiography (CR) system designe… | 2003 |
| * | K974597 | Adc Compact (Agfa Diagnostic Center)Summary page 1…aphy (CR) System Classification Name: Solid State X-Ray Imager (per 21 CFR 892.1650) Predicate Devices: ~ Alara CRystalView CR System S10(k)y# KO032210 Agfa ADC Compact K974597 Product Description: The Alara CRystalView® R200 is a desktop Computed Radiography (CR) system designed to generate digital x-r… | 1998 |
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 |
|---|---|---|---|
| K062390 | Crystalview R200 | 2006 | 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 15 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K062390 (Alara, Inc., 2006) has gone furthest, with 0 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 | — |
What is it indicated for?
CRystalView R200 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures.
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/K061538 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061538: Alara Crystalview Computed Radiography System, Model R200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061538
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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