CARPL

Primary DI
00860015443526
Brand
CARPL
Company
Carpl.AI, Inc.
Model
V2
Device description
CARPL, a web-based PACS and radiology workflow management device, used for viewing and assessing DICOMimages Ex: DX, DR, CR, CT, MR, US, RF and 2D/3D mammography. It gathers digital images and information from avariety of sources that adhere to the DICOM standard. These sources encompass a range of devices, including digital andcomputed radiographic equipment, CT and MR scanners, ultrasound and RF machines, PET units, secondary capturetools, imaging gateways. CARPL enables the storage, transmission, processing, and visualization of images and datawithin 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 inmammography. Lossy compressed Mammographic images and digitized film screen images must not be reviewed forprimary image interpretation on the CARPL. To ensure accurate interpretation, mammographic images should only beevaluated 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.
Published
2026-02-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232891000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232891000CARPL (CARPL)Carpl Ai, Inc.2024-03-27LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860015443526PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860015443526008600154435268600154435260860015443526

GMDN Terms#

Term, Definition table
TermDefinition
Radiology DICOM image processing application softwareA software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119393209
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00086001291630CARPLV22026-01-07

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Primary DI, Brand, Company table
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