510(k) · Cleared
ClearedBone Suppression Software
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 Mar 11, 2014 as substantially equivalent to K060137 (Eastman Kodak Company, 2006) and 1 other predicate after a 119-day review. Its family tree reaches back 6 generations to 1986.
- Decided
- Mar 11, 2014
- Review
- 119 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K862120 (1986). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK862120 SCX SystemGeneral Electric Co. · 1986 · Recalled
- 5 generations backK982196 Digital Radiographic Imaging SystemGE Medical Systems · 1998
- 4 generations backK992066 Revolution TX/I Digital Radiographic Table SystemGE Medical Systems · 1999
- 3 generations backK012389 Revolution XR/D Digital Radiographic Imaging SystemGe Medical Systems, Inc. · 2001 · Recalled
- 2 generations backK013481 Dual Energy and Tissue Equalization Software OptionGE Medical Systems · 2001
- 1 generation backK092363 Softview, Model 2.01Riverain Medical Group · 2010
- This deviceK133442 Bone Suppression SoftwareCarestream Health, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K862120 | SCX System | General Electric Co. | 1986 | 3 |
| −5 | K982196 | Digital Radiographic Imaging System | GE Medical Systems | 1998 | — |
| −4 | K992066 | Revolution TX/I Digital Radiographic Table System | GE Medical Systems | 1999 | — |
| −3 | K012389 | Revolution XR/D Digital Radiographic Imaging System | Ge Medical Systems, Inc. | 2001 | 4 |
| −2 | K013481 | Dual Energy and Tissue Equalization Software Option | GE Medical Systems | 2001 | — |
| −1 | K092363 | Softview, Model 2.01 | Riverain Medical Group | 2010 | — |
| 0 (this device) | K133442 | Bone Suppression Software | Carestream Health, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K060137 | Kodak Eclipse Image Processing SoftwareSummary page 1…Kodak Eclipse Image processing Software Manufactured by Carestream Health. Inc. 5 10(k) No. - K060 13 7 (May 16, 2006) Softview. Model 2.01 Manufactured by Ri… | 2006 |
| * | K092363 | Softview, Model 2.01Summary page 1…Softview. Model 2.01 Manufactured by Riverain Medical Group 5 10(k) No. - K092363 (March 18. 2010) Device Description: The Bone Suppression Software is a soflware component for use on diagnostic x-ray systems… | 2010 |
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 28 years and passes through 5 companies; a new generation was cleared every 4.0 years on median.
- 3 of the 8 ancestors have a recall of any class.
- 4 other devices also cite its predicate K060137.
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. 2014, 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 software's intended use is to assist diagnosis of chest pathology by minimizing anatomical distractions such as the ribs and clavicle in chest x-ray images.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133442 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133442: Bone Suppression Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133442
Report an extraction error
Are you the manufacturer?
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