510(k) · Cleared
ClearediPETcertum (v1.0)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Claritas Healthtech Pte, Ltd. · LLZ System, Image Processing, Radiological
Cleared on Aug 5, 2025 as substantially equivalent to K213140 (Claritas Healthtech Pte, Ltd., 2021) after a 221-day review. Its family tree reaches back 6 generations to 1992.
- Decided
- Aug 5, 2025
- Review
- 221 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K922470 (1992). No later device cites it as a predicate yet.
- Root · 6 generations backK922470 Ies, Image Enhancement SystemOpen Mri, Inc. · 1992
- 5 generations backK993802 Sharpview Image Enhancement SystemContext Vision AB · 2000
- 4 generations backK024028 Sharp View Image Enhancement SystemContext Vision AB · 2003
- 3 generations backK063391 Sapheneia ClaritySapheneia Commercial Products AB · 2007
- 2 generations backK182336 SubtlePETSubtle Medical, Inc. · 2018
- 1 generation backK213140 Claritas iPETClaritas Healthtech Pte, Ltd. · 2021
- This deviceK244016 iPETcertum (v1.0)Claritas Healthtech Pte, Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K922470 | Ies, Image Enhancement System | Open Mri, Inc. | 1992 | — |
| −5 | K993802 | Sharpview Image Enhancement System | Context Vision AB | 2000 | — |
| −4 | K024028 | Sharp View Image Enhancement System | Context Vision AB | 2003 | — |
| −3 | K063391 | Sapheneia Clarity | Sapheneia Commercial Products AB | 2007 | — |
| −2 | K182336 | SubtlePET | Subtle Medical, Inc. | 2018 | — |
| −1 | K213140 | Claritas iPET | Claritas Healthtech Pte, Ltd. | 2021 | — |
| 0 (this device) | K244016 | iPETcertum (v1.0) | Claritas Healthtech Pte, Ltd. | 2025 | — |
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 LLZ? 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 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 |
|---|---|---|---|
| * | K213140 | Claritas iPETSummary page 5…Class II Product Code: LLZ 3. Equivalence Claimed to Predicate Device The iPETcertum device is equivalent to the Claritas iPET (K213140) device, manufactured by Claritas HealthTech Pte Ltd. iPETcertum (v1.0) 510(k)… | 2021 |
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 33 years and passes through 5 companies; a new generation was cleared every 4.3 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K213140.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
iPETcertum is an image processing software intended for use by radiologists and nuclear medicine physicians for noise reduction, sharpening, resolution improvement, and optional segmentation based on uptake value in PET images (including PET/CT and PET/MRI) obtained with any kind of radionuclides, e.g. fluorodeoxyglucose (FDG). Enhanced images can be saved in DICOM, NIfTI or ECAT files and exist in conjunction with original images.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K244016 · printed Nov 4, 2026
Cite this page
510(k) Report. “K244016: iPETcertum (v1.0).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K244016
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