510(k) · Cleared
ClearedPrecision DL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare · KPS System, Tomography, Computed, Emission
Cleared on Apr 27, 2023 as substantially equivalent to K221932 (GE Healthcare, 2022) after a 192-day review. Its family tree reaches back 10 generations to 2001.
- Decided
- Apr 27, 2023
- Review
- 192 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K010641 (2001). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
- 6 generations between
- 3 generations backK161574 Discovery MIGe Medical Systems, LLC · 2016 · Recalled
- 2 generations backK211846 Discovery MI Gen2Ge Medical Systems, LLC · 2021
- 1 generation backK221932 Omni LegendGE Healthcare · 2022 · Recalled
- This deviceK223212 Precision DLGE Healthcare · 2023
Show all 10 generations
- Root · 10 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
- 9 generations backK023988 GE Discovery LS SystemGE Medical Systems · 2003 · Recalled
- 8 generations backK040172 Modification to GE Discovery LS SystemGE Medical Systems · 2004 · Recalled
- 7 generations backK041543 GE Discovery STGE Healthcare · 2004 · Recalled
- 6 generations backK050559 GE Discovery VCT SystemGE Medical Systems · 2005 · Recalled
- 5 generations backK081496 Optima Pet/CT 560Ge Medical Systems, LLC · 2008 · Recalled
- 4 generations backK133657 Discovery Pet/CT 710Ge Medical Systems, LLC · 2014 · Recalled
- 3 generations backK161574 Discovery MIGe Medical Systems, LLC · 2016 · Recalled
- 2 generations backK211846 Discovery MI Gen2Ge Medical Systems, LLC · 2021
- 1 generation backK221932 Omni LegendGE Healthcare · 2022 · Recalled
- This deviceK223212 Precision DLGE Healthcare · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K010641 | GE CT-Pet System | Ge Medical Systems, Inc. | 2001 | — |
| −9 | K023988 | GE Discovery LS System | GE Medical Systems | 2003 | 1 |
| −8 | K040172 | Modification to GE Discovery LS System | GE Medical Systems | 2004 | 5 |
| −7 | K041543 | GE Discovery ST | GE Healthcare | 2004 | 1 |
| −6 | K050559 | GE Discovery VCT System | GE Medical Systems | 2005 | 1 |
| −5 | K081496 | Optima Pet/CT 560 | Ge Medical Systems, LLC | 2008 | 7 |
| −4 | K133657 | Discovery Pet/CT 710 | Ge Medical Systems, LLC | 2014 | 4 |
| −3 | K161574 | Discovery MI | Ge Medical Systems, LLC | 2016 | 3 |
| −2 | K211846 | Discovery MI Gen2 | Ge Medical Systems, LLC | 2021 | — |
| −1 | K221932 | Omni Legend | GE Healthcare | 2022 | 1 |
| 0 (this device) | K223212 | Precision DL | GE Healthcare | 2023 | — |
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.
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 22 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 9 of the 12 ancestors have a recall of any class.
- 1 other device also cites its predicate K221932.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
Precision DL is a deep learning-based image processing method intended to enhance image quality of non-ToF PET images for clinical oncology purpose, using F-18 FDG. Precision DL may be used for patients of all ages.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223212 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223212: Precision DL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223212
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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