Embryo Image Assessment System, Assisted Reproduction

PBH · Class II — Moderate Risk (510(k) clearance required) · Obstetrics/Gynecology · 21 CFR 884.6195

Classification

FDA Product Code: PBH
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 884.6195
Review panel: OB
Medical specialty: Obstetrics/Gynecology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

The device will obtain and analyze light microscopy images of developing embryos. This device provides information to aid in the selection of embryo(s) for transfer when there are multiple embryos deemed suitable for transfer or freezing .

Market data

Cleared 510(k) submissions: 4
Registered establishments: 3

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown