510(k) clearance
MAGENTA BLAST
- 510(k) number
- K261736
- Applicant
- Future Fertility, Inc.
- Decision date
- Sep 18, 2026
- Date received
- May 27, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- PBH
- Device type
- Embryo Image Assessment System, Assisted Reproduction
- Device class
- Class II
- Regulation
- 21 CFR 884.6195
- Advisory committee
- Obstetrics/Gynecology
- Statement or summary
- Summary
- Third party
- N
- Location
- Toronto, CA