510(k) · Cleared
ClearedSmartGrid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carestream Health · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Mar 21, 2017 as substantially equivalent to K141765 (Fujifilm Medical Systems U.S.A, Inc., 2014) after a 131-day review. Its family tree reaches back 11 generations to 1998. 1 later device descends from it.
- Decided
- Mar 21, 2017
- Review
- 131 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K981556 (1998). 18 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 7 generations between
- 3 generations backK111548 Wireless/Wired FDR D-Evo Flat Pancel Detector System Model DR-ID600…Fujifilm Medical System U.S.A., Inc. · 2011
- 2 generations backK132509 FDR D-Evo Flat Panel Detector SystemFujifilm Medical Systems U.S.A, Inc. · 2013
- 1 generation backK141765 FDR D-Evo Flat Panel Detector SystemFujifilm Medical Systems U.S.A, Inc. · 2014
- This deviceK163157 SmartGridCarestream Health · 2017
- Descendant · cites it directly · 0 of its ownK180667 SmartGridCarestream Health, Inc. · 2018
Show all 11 generations
- Root · 11 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 10 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 9 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 8 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- 7 generations backK060433 Digital Radiography Cxdi-50CCanon, Inc. · 2006
- 6 generations backK091545 Digital Radiography Cxdi-60CCanon, Inc. · 2009
- 5 generations backK102012 Digital RadiographyCanon Inc. -Medical Equipment Group · 2010 · Recalled
- 4 generations backK103596 Wireless/Wired FDR D-Evo Flat Panel DetectorFujifilm Medical Systems U.S.A, Inc. · 2011
- 3 generations backK111548 Wireless/Wired FDR D-Evo Flat Pancel Detector System Model DR-ID600…Fujifilm Medical System U.S.A., Inc. · 2011
- 2 generations backK132509 FDR D-Evo Flat Panel Detector SystemFujifilm Medical Systems U.S.A, Inc. · 2013
- 1 generation backK141765 FDR D-Evo Flat Panel Detector SystemFujifilm Medical Systems U.S.A, Inc. · 2014
- This deviceK163157 SmartGridCarestream Health · 2017
Most influential descendants
Showing 1 of 1 · See all- K180667SmartGridCarestream Health, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −10 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −9 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −8 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| −7 | K060433 | Digital Radiography Cxdi-50C | Canon, Inc. | 2006 | — |
| −6 | K091545 | Digital Radiography Cxdi-60C | Canon, Inc. | 2009 | — |
| −5 | K102012 | Digital Radiography | Canon Inc. -Medical Equipment Group | 2010 | 1 |
| −4 | K103596 | Wireless/Wired FDR D-Evo Flat Panel Detector | Fujifilm Medical Systems U.S.A, Inc. | 2011 | — |
| −3 | K111548 | Wireless/Wired FDR D-Evo Flat Pancel Detector System Model DR-ID600 W/DR-ID611SE | Fujifilm Medical System U.S.A., Inc. | 2011 | — |
| −2 | K132509 | FDR D-Evo Flat Panel Detector System | Fujifilm Medical Systems U.S.A, Inc. | 2013 | — |
| −1 | K141765 | FDR D-Evo Flat Panel Detector System | Fujifilm Medical Systems U.S.A, Inc. | 2014 | — |
| 0 (this device) | K163157 | SmartGrid | Carestream Health | 2017 | — |
| +1 | K180667 | SmartGrid | Carestream Health, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 |
|---|---|---|---|
| * | K141765 | FDR D-Evo Flat Panel Detector SystemSummary page 4…Manufactured by FujiFilm Medical Systems USA, Inc. 510(k) No. – K141765 (October 3, 2014) Device Description: The SmartGrid software is designed to improve contrast and reduce the appearance of… | 2014 |
| † | K060137 | Kodak Eclipse Image Processing Software | 2006 |
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 |
|---|---|---|---|
| K180667 | SmartGrid | 2018 | 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 19 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 18 ancestors have a recall of any class.
- Of its descendants, K180667 (Carestream Health, Inc., 2018) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K141765.
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. 2017, 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?
SmartGrid feature is a software option that provides, upon request by user, a diagnostic radiograph image with a reduction in visible x-ray scatter similar to the effect of an anti-scatter grid.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163157 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163157: SmartGrid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163157
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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