510(k) · Cleared
Recalled · Class II · 2019Discovery IQ
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems, LLC · KPS System, Tomography, Computed, Emission
Cleared on Sep 18, 2014 as substantially equivalent to K133657 (Ge Medical Systems, LLC, 2014) after a 106-day review. Its family tree reaches back 7 generations to 2001. It has been recalled 3 times.
- Decided
- Sep 18, 2014
- Review
- 106 days
- Class
- Class II
- Product code
- KPS
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 7 generations to K010641 (2001). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
- 6 generations backK023988 GE Discovery LS SystemGE Medical Systems · 2003 · Recalled
- 5 generations backK040172 Modification to GE Discovery LS SystemGE Medical Systems · 2004 · Recalled
- 4 generations backK041543 GE Discovery STGE Healthcare · 2004 · Recalled
- 3 generations backK050559 GE Discovery VCT SystemGE Medical Systems · 2005 · Recalled
- 2 generations backK081496 Optima Pet/CT 560Ge Medical Systems, LLC · 2008 · Recalled
- 1 generation backK133657 Discovery Pet/CT 710Ge Medical Systems, LLC · 2014 · Recalled
- This deviceK141477 Discovery IQGe Medical Systems, LLC · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K010641 | GE CT-Pet System | Ge Medical Systems, Inc. | 2001 | — |
| −6 | K023988 | GE Discovery LS System | GE Medical Systems | 2003 | 1 |
| −5 | K040172 | Modification to GE Discovery LS System | GE Medical Systems | 2004 | 5 |
| −4 | K041543 | GE Discovery ST | GE Healthcare | 2004 | 1 |
| −3 | K050559 | GE Discovery VCT System | GE Medical Systems | 2005 | 1 |
| −2 | K081496 | Optima Pet/CT 560 | Ge Medical Systems, LLC | 2008 | 7 |
| −1 | K133657 | Discovery Pet/CT 710 | Ge Medical Systems, LLC | 2014 | 4 |
| 0 (this device) | K141477 | Discovery IQ | Ge Medical Systems, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 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 KPS? 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 KPS device
- #1 K253564 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI…score 18.6 · 17 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 |
|---|---|---|---|
| * | K133657 | Discovery Pet/CT 710Summary page 4…ers on systems with the 2m scan range option. Identification of Legally Marketed Equivalent Devices Discovery PET/CT 710 GE Medical Systems LLC K133657 5-2… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 12, 2019 | Class II | Z-1748-2019 | Radiation Control for Health and Safety Act | GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure |
| May 24, 2018 | Class II | Z-2578-2018 | Component change control | Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply). |
| May 19, 2017 | Class II | Z-2192-2017 | Software design | It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 7 of the 9 ancestors have a recall of any class.
- 1 other device also cites its predicate K133657.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · KPS
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPS
65in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPS
16in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · KPS
36in 2025
MAUDE reports naming product code KPS, 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 | 8 | 38 | 22 | 38 |
| 2008 | 17 | 25 | 16 | 11 |
| 2009 | 9 | 42 | 14 | 15 |
| 2010 | 3 | 91 | 4 | 44 |
| 2011 | 7 | 28 | 34 | 56 |
| 2012 | 6 | 94 | 13 | 34 |
| 2013 | 11 | 84 | 13 | 240 |
| 2014 | 11 | 92 | 18 | 33 |
| 2015 | 3 | 112 | 5 | 24 |
| 2016 | 11 | 65 | 16 | 10 |
| 2017 | 11 | 104 | 11 | 31 |
| 2018 | 13 | 59 | 12 (3) | 26 |
| 2019 | 3 | 60 | 5 (5) | 105 |
| 2020 | 12 | 72 | 8 | 22 |
| 2021 | 15 | 66 | 4 | 10 |
| 2022 | 5 | 60 | 8 (6) | 15 |
| 2023 | 12 | 63 | 6 (3) | 22 |
| 2024 | 11 | 59 | 15 | 23 |
| 2025 | 12 | 65 | 16 | 36 |
| 2026 | 6 | 67 | 6 | — |
What is it indicated for?
GE Discovery IQ PET/CT system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The system is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions in patients of all ages. This…
Read the full statement (127 words)
GE Discovery IQ PET/CT system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.
The system is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions in patients of all ages. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning.
The system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141477 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141477: Discovery IQ.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141477
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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