Morph— 510(k) K260032
Substantially EquivalentBeauBrain Healthcare, Inc.
FDA 510(k) clearance K260032 for Morph, Substantially Equivalent on 2026-05-13. Applicant: BeauBrain Healthcare, Inc.. Device class: 2.
Summary
BeauBrain Healthcare's Morph is filed under QIH, automated radiological image processing software. The record doesn't describe it beyond its name and that code name.
Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel, and the submission was a Traditional 510(k).
BeauBrain filed from Seoul, South Korea. The decision came 127 calendar days after receipt (January 6 to May 13, 2026).
Clearance details
- Applicant
- BeauBrain Healthcare, Inc.
- Product code
- Product code QIH
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seoul, KR
Recent devices under product code QIH
view allData sourced from openFDA. This site is unofficial and independent of the FDA.