510(k) · Cleared
ClearedInfinitt G3 Pacs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Infinitt Co., Ltd. · LLZ System, Image Processing, Radiological
Cleared on Nov 8, 2005 as substantially equivalent to K042313 (Dynamic Imaging, Inc., 2004) after a 54-day review. Its family tree reaches back 4 generations to 1994. 20 later devices descend from it.
- Decided
- Nov 8, 2005
- Review
- 54 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K942120 (1994). 7 ancestors in all. 20 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK942120 Advantage Windows Diagnostic X-Ray WorkstationGE Medical Systems · 1994
- 3 generations backK013630 Isite RadiologyStentor, Inc. · 2001
- 2 generations backK031311 Integradweb by Dynamic Imaging, Inc.Dynamic Imaging, Inc. · 2003
- 1 generation backK042313 Integradweb MPR/MipDynamic Imaging, Inc. · 2004
- This deviceK052545 Infinitt G3 PacsInfinitt Co., Ltd. · 2005
- Descendant · cites it directly · 6 of its ownK163290 INFINITT ULiteInfinitt Co., Ltd. · 2017
- Descendant · cites it directly · 6 of its ownK082990 Infinitt XelisInfinitt Co., Ltd. · 2008
- Descendant · 2 generations on · 5 of its ownK211480 NubeXTechheim Co., Ltd. · 2021
- Descendant · 3 generations on · 4 of its ownK222781 AugmentoDeeptek Medical Imaging Private Limited · 2023
- Descendant · cites it directly · 3 of its ownK172803 Infinitt PACS 7.0Infinitt Healthcare Co., Ltd. · 2017
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K163290INFINITT ULiteInfinitt Co., Ltd. · 2017 · cites it directly6descendants
- K082990Infinitt XelisInfinitt Co., Ltd. · 2008 · cites it directly6descendants
- K211480NubeXTechheim Co., Ltd. · 2021 · 2 generations on5descendants
- K222781AugmentoDeeptek Medical Imaging Private Limited · 2023 · 3 generations on4descendants
- K172803Infinitt PACS 7.0Infinitt Healthcare Co., Ltd. · 2017 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K942120 | Advantage Windows Diagnostic X-Ray Workstation | GE Medical Systems | 1994 | — |
| −3 | K013630 | Isite Radiology | Stentor, Inc. | 2001 | — |
| −2 | K031311 | Integradweb by Dynamic Imaging, Inc. | Dynamic Imaging, Inc. | 2003 | — |
| −1 | K042313 | Integradweb MPR/Mip | Dynamic Imaging, Inc. | 2004 | — |
| 0 (this device) | K052545 | Infinitt G3 Pacs | Infinitt Co., Ltd. | 2005 | — |
| +1 | K163290 | INFINITT ULite | Infinitt Co., Ltd. | 2017 | — |
| +1 | K082990 | Infinitt Xelis | Infinitt Co., Ltd. | 2008 | — |
| +2 | K211480 | NubeX | Techheim Co., Ltd. | 2021 | — |
| +3 | K222781 | Augmento | Deeptek Medical Imaging Private Limited | 2023 | — |
| +1 | K172803 | Infinitt PACS 7.0 | Infinitt Healthcare Co., Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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 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 |
|---|---|---|---|
| * | K042313 | Integradweb MPR/MipSummary page 1…assification: 892.2050 System, Image Processing Product Code: LLZ Predicate Device: 21 CFR 807. 92(a)(3) 510(k) Number K042313 Regulation Number 892.2050 Device Name INTEGRADWEB MPR/MIP Applicant… | 2004 |
What descends from it? (20)
See all 204 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 11 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K163290 (Infinitt Co., Ltd., 2017) has gone furthest, with 6 descendants of its own.
- 5 other devices also cite its predicate K042313.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Infinitt G3 PACS is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, and displayed within the system or across computer networks at distributed locations. Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image…
Read the full statement (111 words)
Infinitt G3 PACS is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, and displayed within the system or across computer networks at distributed locations. Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052545 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052545: Infinitt G3 Pacs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052545
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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