510(k) · Cleared
ClearedImaging system of positron emission and X-ray computed tomography (DigitMI 930)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Raysolution Healthcare Co., Ltd. · KPS System, Tomography, Computed, Emission
Cleared on Jan 27, 2025 as substantially equivalent to K161574 (Ge Medical Systems, LLC, 2016) after a 266-day review. Its family tree reaches back 8 generations to 2001.
- Decided
- Jan 27, 2025
- Review
- 266 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K010641 (2001). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
- 7 generations backK023988 GE Discovery LS SystemGE Medical Systems · 2003 · Recalled
- 6 generations backK040172 Modification to GE Discovery LS SystemGE Medical Systems · 2004 · Recalled
- 5 generations backK041543 GE Discovery STGE Healthcare · 2004 · Recalled
- 4 generations backK050559 GE Discovery VCT SystemGE Medical Systems · 2005 · Recalled
- 3 generations backK081496 Optima Pet/CT 560Ge Medical Systems, LLC · 2008 · Recalled
- 2 generations backK133657 Discovery Pet/CT 710Ge Medical Systems, LLC · 2014 · Recalled
- 1 generation backK161574 Discovery MIGe Medical Systems, LLC · 2016 · Recalled
- This deviceK241266 Imaging system of positron emission and X-ray computed tomography…Raysolution Healthcare Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K010641 | GE CT-Pet System | Ge Medical Systems, Inc. | 2001 | — |
| −7 | K023988 | GE Discovery LS System | GE Medical Systems | 2003 | 1 |
| −6 | K040172 | Modification to GE Discovery LS System | GE Medical Systems | 2004 | 5 |
| −5 | K041543 | GE Discovery ST | GE Healthcare | 2004 | 1 |
| −4 | K050559 | GE Discovery VCT System | GE Medical Systems | 2005 | 1 |
| −3 | K081496 | Optima Pet/CT 560 | Ge Medical Systems, LLC | 2008 | 7 |
| −2 | K133657 | Discovery Pet/CT 710 | Ge Medical Systems, LLC | 2014 | 4 |
| −1 | K161574 | Discovery MI | Ge Medical Systems, LLC | 2016 | 3 |
| 0 (this device) | K241266 | Imaging system of positron emission and X-ray computed tomography (DigitMI 930) | Raysolution Healthcare Co., Ltd. | 2025 | — |
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 |
|---|---|---|---|
| * | K161574 | Discovery MISummary page 8…e PET part consists of a 72 ring LYSO detector, while the CT part has 64 physical rows of detectors. Predicate Device Identification Predicate Device: 510(k) Number: K161574 Product Name: Discovery MI Manufacturer: GE Medical Systems, L.L.C. Non-Clinical Test Conclusion Non clinical tests were conduc… | 2016 |
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 24 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 8 of the 10 ancestors have a recall of any class.
- 1 other device also cites its predicate K161574.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
The Imaging system of positron emission and X-ray computed tomography is a PET/CT system for producing attenuation corrected PET images. It is intended to be used by qualified health care professionals for imaging the distribution and localization of any positron-emitting radiopharmaceutical in a patient, for the assessment of metabolic (molecular) and physiologic function in patients, with a wide range of sizes and extent of disease, of all ages.…
Read the full statement (301 words)
The Imaging system of positron emission and X-ray computed tomography is a PET/CT system for producing attenuation corrected PET images. It is intended to be used by qualified health care professionals for imaging the distribution and localization of any positron-emitting radiopharmaceutical in a patient, for the assessment of metabolic (molecular) and physiologic function in patients, with a wide range of sizes and extent of disease, of all ages.
Imaging system of positron emission and X-ray computed tomography is intended to image the whole body, head, heart, brain, lung, breast, bone, the gastrointestinal and lymphatic systems, and other organs. The images produced by the system may be used by physicians to aid in radiotherapy treatment planning, therapy guidance and monitoring, and in interventional radiology procedures. The images may also be used for precise functional and anatomical mapping (localization, registration, and fusion).
When used with radiopharmaceuticals approved by the regulatory authority in the country of use, the raw and image data is an aid in; detection, localization, evaluation, diagnosis, staging, restaging, monitoring, and/or follow up, of abnormalities, lesions, tumors, inflammation, infection, organ function, disorders, and/or disease, such as, but not limited to, those in oncology, cardiology, and neurology. Examples of which are:
Cardiology:
Cardiovascular disease
Myocardial perfusion
Myocardial viability
Cardiac inflammation
Coronary artery disease
Neurology:
Epilepsy
Dementia, such as Alzheimer's disease, Lewy body dementia, Parkinson's disease with dementia, and frontotemporal dementia.
Movement disorders, such as Parkinson's and Huntington's disease
Tumors
Inflammation
Cerebrovascular disease such as acute stroke, chronic and acute ischemia
Traumatic Brain Injury (TBI)
Oncology/Cancer:
Non-Small Cell Lung Cancer
Small Cell Lung Cancer
Breast Cancer
Prostate Cancer
Hodgkin disease
Non-Hodgkin lymphoma
Colorectal Cancer
Melanoma
Imaging system of positron emission and X-ray computed tomography is also intended for stand-alone, diagnostic CT imaging in accordance with the stand-alone CT system's cleared indications for use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K241266 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241266: Imaging system of positron emission and X-ray computed tomography (DigitMI 930).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241266
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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