ArteraAI Breast

Primary DI
00850062141032
Brand
ArteraAI Breast
Company
Artera Inc.
Model
1.x.x
Published
2026-10-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
SHWPathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SHWPathology Software Algorithm Device Analyzing Digital Images For Breast Cancer PrognosisPathology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K254115000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K254115000ArteraAI BreastArtera, Inc.2026-05-04SHW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850062141032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850062141032008500621410328500621410320850062141032

GMDN Terms#

Term, Definition table
TermDefinition
Cancer risk assessment interpretive software IVDAn in vitro diagnostic interpretive software program intended to be used in the assessment of risk for developing cancer (e.g., breast, ovarian, prostate, lung, liver, gastric, pancreatic, colorectal). It uses specific algorithms to combine and correlate patient demographics, clinical observations, and the in vitro diagnostic results of the qualitative and/or quantitative detection of one or multiple cancer-specific biomarkers in a clinical specimen to establish an individual risk score that may be used to guide patient management.

Contacts#

Phone, Email table
PhoneEmail
+1 650 239 7018support@artera.ai

Regulatory Flags#

DUNS number
118225232
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false