510(k) · Cleared
ClearedCarpl (Carpl)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carpl Ai, Inc. · LLZ System, Image Processing, Radiological
Cleared on Mar 27, 2024 as substantially equivalent to K222781 (Deeptek Medical Imaging Private Limited, 2023) after a 191-day review. Its family tree reaches back 8 generations to 1994. 2 later devices descend from it.
- Decided
- Mar 27, 2024
- Review
- 191 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K942120 (1994). 11 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK942120 Advantage Windows Diagnostic X-Ray WorkstationGE Medical Systems · 1994
- 7 generations backK013630 Isite RadiologyStentor, Inc. · 2001
- 6 generations backK031311 Integradweb by Dynamic Imaging, Inc.Dynamic Imaging, Inc. · 2003
- 5 generations backK042313 Integradweb MPR/MipDynamic Imaging, Inc. · 2004
- 4 generations backK052545 Infinitt G3 PacsInfinitt Co., Ltd. · 2005
- 3 generations backK163290 INFINITT ULiteInfinitt Co., Ltd. · 2017
- 2 generations backK211480 NubeXTechheim Co., Ltd. · 2021
- 1 generation backK222781 AugmentoDeeptek Medical Imaging Private Limited · 2023
- This deviceK232891 Carpl (Carpl)Carpl Ai, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK260936 RadioViewAINeurocareai, Inc. (Dba Savelife.Ai) · 2026
- Descendant · cites it directly · 0 of its ownK253008 maiLinkMaihub Corp. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K942120 | Advantage Windows Diagnostic X-Ray Workstation | GE Medical Systems | 1994 | — |
| −7 | K013630 | Isite Radiology | Stentor, Inc. | 2001 | — |
| −6 | K031311 | Integradweb by Dynamic Imaging, Inc. | Dynamic Imaging, Inc. | 2003 | — |
| −5 | K042313 | Integradweb MPR/Mip | Dynamic Imaging, Inc. | 2004 | — |
| −4 | K052545 | Infinitt G3 Pacs | Infinitt Co., Ltd. | 2005 | — |
| −3 | K163290 | INFINITT ULite | Infinitt Co., Ltd. | 2017 | — |
| −2 | K211480 | NubeX | Techheim Co., Ltd. | 2021 | — |
| −1 | K222781 | Augmento | Deeptek Medical Imaging Private Limited | 2023 | — |
| 0 (this device) | K232891 | Carpl (Carpl) | Carpl Ai, Inc. | 2024 | — |
| +1 | K260936 | RadioViewAI | Neurocareai, Inc. (Dba Savelife.Ai) | 2026 | — |
| +1 | K253008 | maiLink | Maihub Corp. | 2026 | — |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K222781 | AugmentoSummary page 4…system, image processing, radiological (21 CFR 892.2050) Regulatory Class: II Product Code: LLZ III. PREDICATE DEVICE Predicate Device: Augmento (K222781) by DeepTek Medical Imaging Private Limited, Class II, CFR 892.2050, classification with product code LLZ. IV. DEVICE DES… | 2023 |
What descends from it? (2)
2 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 30 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K260936 (Neurocareai, Inc. (Dba Savelife.Ai), 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K222781.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
CARPL, a web-based PACS and radiology workflow management device, used for viewing and assessing DICOM images Ex: DX, DR, CR, CT, MR, US, RF and 2D/3D mammography. It gathers digital images and information from a variety of sources that adhere to the DICOM standard. These sources encompass a range of devices, including digital and computed radiographic equipment, CT and MR scanners, ultrasound and RF machines, PET units, secondary capture tools, imaging…
Read the full statement (173 words)
CARPL, a web-based PACS and radiology workflow management device, used for viewing and assessing DICOM images Ex: DX, DR, CR, CT, MR, US, RF and 2D/3D mammography. It gathers digital images and information from a variety of sources that adhere to the DICOM standard. These sources encompass a range of devices, including digital and computed radiographic equipment, CT and MR scanners, ultrasound and RF machines, PET units, secondary capture tools, imaging gateways. CARPL enables the storage, transmission, processing, and visualization of images and data within the system itself or over computer networks spanning different locations.
Only pre-processed DICOM images specifically intended for presentation are suitable for primary image diagnosis in mammography. Lossy compressed Mammographic images and digitized film screen images must not be reviewed for primary image interpretation on the CARPL. To ensure accurate interpretation, mammographic images should only be evaluated on a monitor that adheres to the technical specifications outlined by the FDA.
This system is designed exclusively for use by proficient and certified medical experts, including physicians, radiologists, and medical technicians.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232891 · printed Nov 4, 2026
Cite this page
510(k) Report. “K232891: Carpl (Carpl).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K232891
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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