510(k) · Cleared
Recalled · Class II · 2012Infinix-Cci
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toshiba America Medical Systems, In.C · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Nov 22, 2011 as substantially equivalent to K081621 (Toshiba America Medical Systems, In.C, 2008) after a 40-day review. Its family tree reaches back 7 generations to 1989. 7 later devices descend from it. It has been recalled once.
- Decided
- Nov 22, 2011
- Review
- 40 days
- Class
- Class II
- Product code
- MQB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 7 generations to K890348 (1989). 19 ancestors in all. 7 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 6 generations backK993037 LCV+ Version 2Ge Medical Systems, Inc. · 2000 · Recalled
- 5 generations backK022322 Innova and Innova 2000 SGe Medical Systems, Inc. · 2002 · Recalled
- 4 generations backK031637 Innova 3100GE Medical Systems · 2003 · Recalled
- 3 generations backK050489 Innova 2100Ge Medical Systems, LLC · 2005 · Recalled
- 2 generations backK052412 Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova…GE Healthcare · 2005 · Recalled
- 1 generation backK081621 Infx-8000C (Infinix CC-I and VC-I)Toshiba America Medical Systems, In.C · 2008 · Recalled
- This deviceK113052 Infinix-CciToshiba America Medical Systems, In.C · 2011
- Descendant · cites it directly · 3 of its ownK152697 Infx-8000C, V6.20Toshibamedical Systems Corporation · 2016 · Recalled
- Descendant · cites it directly · 3 of its ownK134025 Aquilion One Vision Self-Propelled Scan Base Kit for Ivr-CTToshibamedical Systems Corporation · 2014
- Descendant · 2 generations on · 2 of its ownK181804 Alphenix, INFX-8000C/B, V8.0Canon Medical Systems Corporation · 2018 · Recalled
- Descendant · cites it directly · 2 of its ownK143223 CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CTToshibamedical Systems Corporation · 2015
- Descendant · 3 generations on · 1 of its ownK210900 Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2Canon Medical Systems Corporation · 2021 · Recalled
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K152697Infx-8000C, V6.20Toshibamedical Systems Corporation · 2016 · cites it directly3descendants
- K134025Aquilion One Vision Self-Propelled Scan Base Kit for Ivr-CTToshibamedical Systems Corporation · 2014 · cites it directly3descendants
- K181804Alphenix, INFX-8000C/B, V8.0Canon Medical Systems Corporation · 2018 · 2 generations on2descendants
- K143223CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CTToshibamedical Systems Corporation · 2015 · cites it directly2descendants
- K210900Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2Canon Medical Systems Corporation · 2021 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K890348 | LC, Cardiac Positioner #B5078A | General Electric Co. | 1989 | 5 |
| −6 | K993037 | LCV+ Version 2 | Ge Medical Systems, Inc. | 2000 | 6 |
| −5 | K022322 | Innova and Innova 2000 S | Ge Medical Systems, Inc. | 2002 | 7 |
| −4 | K031637 | Innova 3100 | GE Medical Systems | 2003 | 25 |
| −3 | K050489 | Innova 2100 | Ge Medical Systems, LLC | 2005 | 27 |
| −2 | K052412 | Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQ | GE Healthcare | 2005 | 50 |
| −1 | K081621 | Infx-8000C (Infinix CC-I and VC-I) | Toshiba America Medical Systems, In.C | 2008 | 1 |
| 0 (this device) | K113052 | Infinix-Cci | Toshiba America Medical Systems, In.C | 2011 | — |
| +1 | K152697 | Infx-8000C, V6.20 | Toshibamedical Systems Corporation | 2016 | 5 |
| +1 | K134025 | Aquilion One Vision Self-Propelled Scan Base Kit for Ivr-CT | Toshibamedical Systems Corporation | 2014 | — |
| +2 | K181804 | Alphenix, INFX-8000C/B, V8.0 | Canon Medical Systems Corporation | 2018 | 3 |
| +1 | K143223 | CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CT | Toshibamedical Systems Corporation | 2015 | — |
| +3 | K210900 | Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2 | Canon Medical Systems Corporation | 2021 | 7 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1998 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2021 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K081621 | Infx-8000C (Infinix CC-I and VC-I)Summary page 1…y imager (flat panel/digital imager) 9. PERFORMANCE STANDARD: 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard 10. PREDICATE DEVICE: INFX-8000C (K081 621) 11. REASON FOR SUBMISSION: Modification of a cleared device 12. DEVICE DESCRIPTION: This device in an x-ray system tha… | 2008 |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 8, 2012 | Class II | Z-0994-2013 | Software design | Lost and incorrect images. When using the "F-Rec" fluoroscopy image acquisition recording option in the "manual mode" an infrequent software error may cause images from another study to be displayed on the monitor. The acquired images may… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 6 companies; a new generation was cleared every 2.6 years on median.
- 15 of the 19 ancestors have a recall of any class.
- Of its descendants, K152697 (Toshibamedical Systems Corporation, 2016) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K081621.
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. 2011, 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?
This device is a digital radiography/fluoroscopy system used in a diagnostic
and interventional angiography configuration. The system is indicated for
use in diagnostic and angiographic procedures for blood vessels in the
heart, brain, abdomen and lower extremities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113052 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113052: Infinix-Cci.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113052
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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