# K232891: Carpl (Carpl)

- Pathway: 510(k) (Traditional)
- Applicant: Carpl Ai, Inc.
- Decided: Mar 27, 2024 after 191 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K942120 (1994). 11 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222781: Augmento, Deeptek Medical Imaging Private Limited (2023) Summary page 4.

## Most influential descendants
- K260936: RadioViewAI (2026), 0 descendants of its own
- K253008: maiLink (2026), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K232891
Methodology: https://510kreport.com/methodology