Embryo Predict

Primary DI
00860008987204
Brand
Embryo Predict
Company
Alife Health Inc.
Model
v1.3.1
Catalog number
200-00201
Device description
Embryo Predict is a software as a medical device (SaMD) that analyzes images of Day 5, 6, and 7 blastocyst-stage embryos (early, expanded, hatching, and hatched) that have already been determined to be suitable for transfer by the embryologist and provides an AI score that is used adjunctively to traditional morphology to aid in the assessment for selection of embryo(s) for transfer that have already been determined to be suitable for transfer by the embryologist.
Published
2026-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
PBHEmbryo Image Assessment System, Assisted Reproduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PBHEmbryo Image Assessment System, Assisted ReproductionObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250781000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250781000Embryo PredictAlife Health2026-05-15PBH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860008987204PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008987204008600089872048600089872040860008987204

GMDN Terms#

Term, Definition table
TermDefinition
Assisted reproduction embryo-assessment softwareAn application software program intended to analyse image data captured by an embryo-assessment microscope camera system to store, and allow comparison/evaluation of, acquired embryo images, to assist embryo selection during assisted reproduction/in vitro fertilization (IVF). Typically it allows the user to store relevant patient medical records, analyse still images and videos of embryonic growth, annotate or categorize images, and may provide decision support. It is intended to be used by healthcare professionals in a clinical setting.

Contacts#

Phone, Email table
PhoneEmail
707-652-9723support@alifehealth.com

Regulatory Flags#

DUNS number
117737142
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05712714675317KIDScore D3Vitrolife A/SPBH2019-11-28