Embryo Image Assessment System, Assisted Reproduction
The Embryo Image Assessment System for Assisted Reproduction is an imaging device that obtains and analyzes light microscopy images of developing embryos during in vitro fertilization (IVF) procedures. It provides information to aid clinicians in selecting embryos for transfer when multiple embryos are deemed suitable for transfer or freezing. It falls under the Obstetrics/Gynecology medical specialty and is classified as a Class 2 device under regulation 884.6195, requiring 510(k) premarket notification. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PBH
- Device Class
- FDA class 2
- Regulation Number
- 884.6195
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
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 .
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K250781 | Embryo Predict | May 15, 2026 | Substantially Equivalent | Alife Health |
| K243851 | CHLOE BLAST | Aug 15, 2025 | Substantially Equivalent | Fairtility , Ltd. |
| K182798 | KIDScore D3 | Jul 19, 2019 | Substantially Equivalent | Vitrolife A/S |
| K142147 | EEVA SYSTEM | Nov 24, 2014 | Substantially Equivalent | Auxogyn, Inc. |
| DEN120015 | EEVA 2.0 | Jun 06, 2014 | Unknown | Auxogyn, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.