CARPL
Basic Information
- Brand Name
- CARPL
- Primary DI
- 00860015443526
- Version / Model
- V2
- Company Name
- Carpl.AI, Inc.
- Labeler DUNS
- 119393209
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-16
- Public Version
- 1
- Public Version Date
- 2026-02-24
- Public Version Status
- New
- Public Device Record Key
- a47fed0a-a54f-440b-a097-d347755af835
Device Description
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LLZ | System, Image Processing, Radiological | Radiology | 892.2050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57812 | Radiology DICOM image processing application software | A 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). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860015443526 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K232891 | 000 |