510(k) · Cleared
ClearedAnyScan 3.0 NM Scanner Family
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mediso Medical Imaging Systems, Ltd. · KPS System, Tomography, Computed, Emission
Cleared on Dec 30, 2025 as substantially equivalent to K200474 (Siemens Medical Solutions USA, Inc., 2020) and 1 other predicate after a 28-day review. Its family tree reaches back 16 generations to 2000. 1 of the 47 devices in its family, counting itself, has a Class I recall.
- Decided
- Dec 30, 2025
- Review
- 28 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 16 generations to K002715 (2000). 46 ancestors in all, the oldest K843696 (1985). No later device cites it as a predicate yet. 1 of the 47 devices in this family, counting this one, has a Class I recall.
- Root · 16 generations backK002715 Ecat Pet ScannerCti Pet Systems, Inc. · 2000 · Recalled
- 12 generations between
- 3 generations backK152880 Biograph Horizon PET/CTSiemens Medical Solutions USA, Inc. · 2016 · Recalled
- 2 generations backK170904 Biograph Horizon PET/CTSiemens Medical Solutions USA, Inc. · 2017 · Recalled
- 1 generation backK193178 Biograph HorizonSiemens Medical Solution USA, Inc. · 2020 · Recalled
- This deviceK253844 AnyScan 3.0 NM Scanner FamilyMediso Medical Imaging Systems, Ltd. · 2025
Show all 16 generations
- Root · 16 generations backK002715 Ecat Pet ScannerCti Pet Systems, Inc. · 2000 · Recalled
- 15 generations backK013504 Modification to: Ecat Lso Pet/CT ScannerCti Pet Systems, Inc. · 2001 · Recalled
- 14 generations backK023518 Ecat Lso Pet/CT 16Cti Pet Systems, Inc. · 2002 · Recalled
- 13 generations backK033431 Lso Pet/CT Hirez and Lso Pet/CT 16 HirezCti Pet Systems, Inc. · 2003 · Recalled
- 12 generations backK042467 Lso Pet/CT Hirez 64Cti Pet Systems, Inc. · 2004 · Recalled
- 11 generations backK050509 Lso Pet/CT Hirez Series, Models 2I, 6I, 16I, 64ICti Pet Systems, Inc. · 2005
- 10 generations backK060060 Biograph 6Siemens Medical Solutions USA, Inc. · 2006
- 9 generations backK060631 Biograph 64 and Biograph 40Siemens Medical Solutions USA, Inc. · 2006 · Recalled
- 8 generations backK081453 Biograph HD FamilySiemens Medical Solutions USA, Inc. · 2008
- 7 generations backK101550 Biograph MCT FamilySiemens Medical Solutions USA, Inc. · 2010
- 6 generations backK113448 Biograph MCT FamilySiemens Medical Solutions USA, Inc. · 2011
- 5 generations backK123737 Biograph MCT FamilySiemens Medical Solutions USA, Inc. · 2013 · Recalled
- 4 generations backK151486 Biograph mCT and mCT Flow PET/CT ScannersSiemens Medical Solutions USA, Inc. · 2015 · Recalled
- 3 generations backK152880 Biograph Horizon PET/CTSiemens Medical Solutions USA, Inc. · 2016 · Recalled
- 2 generations backK170904 Biograph Horizon PET/CTSiemens Medical Solutions USA, Inc. · 2017 · Recalled
- 1 generation backK193178 Biograph HorizonSiemens Medical Solution USA, Inc. · 2020 · Recalled
- This deviceK253844 AnyScan 3.0 NM Scanner FamilyMediso Medical Imaging Systems, Ltd. · 2025
Class I recalls in this family
- K991841 Hawkeye Option for Dual-Head Variable Angle…7 generations back · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K002715 | Ecat Pet Scanner | Cti Pet Systems, Inc. | 2000 | 2 |
| −15 | K013504 | Modification to: Ecat Lso Pet/CT Scanner | Cti Pet Systems, Inc. | 2001 | 2 |
| −14 | K023518 | Ecat Lso Pet/CT 16 | Cti Pet Systems, Inc. | 2002 | 1 |
| −13 | K033431 | Lso Pet/CT Hirez and Lso Pet/CT 16 Hirez | Cti Pet Systems, Inc. | 2003 | 1 |
| −12 | K042467 | Lso Pet/CT Hirez 64 | Cti Pet Systems, Inc. | 2004 | 1 |
| −11 | K050509 | Lso Pet/CT Hirez Series, Models 2I, 6I, 16I, 64I | Cti Pet Systems, Inc. | 2005 | — |
| −10 | K060060 | Biograph 6 | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −9 | K060631 | Biograph 64 and Biograph 40 | Siemens Medical Solutions USA, Inc. | 2006 | 3 |
| −8 | K081453 | Biograph HD Family | Siemens Medical Solutions USA, Inc. | 2008 | — |
| −7 | K101550 | Biograph MCT Family | Siemens Medical Solutions USA, Inc. | 2010 | — |
| −6 | K113448 | Biograph MCT Family | Siemens Medical Solutions USA, Inc. | 2011 | — |
| −5 | K123737 | Biograph MCT Family | Siemens Medical Solutions USA, Inc. | 2013 | 17 |
| −4 | K151486 | Biograph mCT and mCT Flow PET/CT Scanners | Siemens Medical Solutions USA, Inc. | 2015 | 11 |
| −3 | K152880 | Biograph Horizon PET/CT | Siemens Medical Solutions USA, Inc. | 2016 | 1 |
| −2 | K170904 | Biograph Horizon PET/CT | Siemens Medical Solutions USA, Inc. | 2017 | 4 |
| −1 | K193178 | Biograph Horizon | Siemens Medical Solution USA, Inc. | 2020 | 1 |
| 0 (this device) | K253844 | AnyScan 3.0 NM Scanner Family | Mediso Medical Imaging Systems, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 1 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 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.
1 device in this family has a Class I recall. 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? (2)
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 |
|---|---|---|---|
| * | K200474 | Symbia 6.7Summary page 6…on (PET/CT) Manufacturer: Siemens Medical Solutions USA, Siemens Medical Solutions Inc USA, Inc. 510(k) K200474 K193178 Clearance: Regulation 21 CFR 892.1200 21 CFR 892.1200 Nu… | 2020 |
| * | K193178 | Biograph HorizonSummary page 6…s Medical Solutions USA, Siemens Medical Solutions Inc USA, Inc. 510(k) K200474 K193178 Clearance: Regulation 21 CFR 892.1200 21 CFR 892.1200 Number: Regulation Emission compu… | 2020 |
| † | K162483 | Symbia Intevo Bold | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K991841Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999 · 7 generations back · ◆ in the 1999 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 29 of the 46 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K200474.
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 AnyScan 3.0 NM Scanner Family is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment…
Read the full statement (314 words)
The AnyScan 3.0 NM Scanner Family is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning or additional uses.
The SPECT subsystem is intended to provide projection and cross-sectional images through computer reconstruction of the data, representing radioisotope distribution in the patient body or in a specific organ using planar and tomographic scanning modes for isotopes with energies up to 588 keV.
CT component is intended to provide cross sectional images of the body by computer reconstruction of xray transmission data providing anatomical information.
The PET component is intended to provide cross- sectional images representing the distribution of tomographic scanning modes.
The SPECT and CT components used together acquire SPECT/CT images. The SPECT images can be corrected for attenuation with the CT images, and can be combined (image registration) to merge the patient's physiological (SPECT) and anatomical (CT) images.
The PET and CT components used together acquire PET/CT images. The PET images can be corrected for attenuation with the CT images, and can be combined (image registration) to merge the patient's physiological (PET) and anatomical (CT) images.
The system maintains independent functionality of the SPECT, CT and PET components, allowing for single modality SPECT, CT and/ or PET diagnostic imaging.
Software: The Nucline software is an acquisition, display and analysis package intended to aid the clinician to extract diagnostic information supported by image assessment tools, image enhancement features and image quantification of pathologies in images produced from SPECT, CT, PET and other imaging modalities.
This CT system can be used for low dose lung cancer screening in high risk populations.*
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253844 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253844: AnyScan 3.0 NM Scanner Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253844
Report an extraction error
Are you the manufacturer?
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