510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PBHClass II

Embryo Image Assessment System, Assisted Reproduction

21 CFR 884.6195 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

PBH is the FDA product code for Embryo Image Assessment System, Assisted Reproduction, a class II device type, regulated under 21 CFR 884.6195. FDA's definition for this code reads: "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". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PBH
Device name
Embryo Image Assessment System, Assisted Reproduction
FDA 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 .
Regulation
21 CFR 884.6195
Device class
Class II
Review panel
Obstetrics/Gynecology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
5
Ingested recalls
0

Clearances, product code PBH

By decision year
5 clearances under product code PBH with a decision year between 2014 and 2026, 2014 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PBH by decision year
YearClearances
20142
20191
20251
20261

Applicants with the most clearances

Product code PBH
Applicants holding the most 510(k) clearances under product code PBH
ApplicantClearances
Auxogyn, Inc.2
Alife Health, Inc.1
Fairtility Ltd.1
Vitrolife Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code