Pathology · 510(k) · 2026
ArteraAI Breast
Artera, Inc.. Cleared by FDA on 4 May 2026 under submission K254115, product code SHW (pathology software algorithm device analyzing digital images for breast cancer prognosis). What FDA's record says, in FDA's words.
Device record · K254115
- Device. ArteraAI BreastDEVICE
- Company. Artera, Inc.COMPANY
- Decision. 4 May 2026, 510(k), substantially equivalent (traditional review); received 19 December 2025DECISION
- Panel. PathologyPANEL
- Product code. SHW, Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer PrognosisCODE
- Regulation. 21 CFR 864.3755, Class IIREG
- Source. FDA database entry · decision document (4 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
ArteraAI Breast is a software only device intended to analyze scanned histopathology whole slide image (WSI) from treatment-naïve breast resection specimens prepared from formalin fixed paraffin-embedded (FFPE) tissue and stained using Hematoxylin & Eosin (H&E) stains. Additional inputs to ArteraAI Breast include the following physician-provided
The product code's definition, from FDA's classification record. A pathology software algorithm device analyzing digital images for breast cancer prognosis is a software intended to analyze digital images acquired from medical imaging devices (for example but not limited to - whole slide imaging scanners). The device provides prognostic risk estimates which are intended to assist physicians with prognostic risk-based decisions along with other clinicopathological factors. The device is not intended to determine a clinical diagnosis.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedpathology slides
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code SHW. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code SHW, in Pathology, from Artera, Inc., or cleared in 2026. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.