510(k) K260032
- Device
- Morph
- Applicant
- BeauBrain Healthcare, Inc.
- 510(k) number
- K260032
- Product code
- QIH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-05-13
- Date received
- 2026-01-06
- Regulation
- 892.2050
- Classification name
- Automated Radiological Image Processing Software
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Hyojin Kim
- Address
- 2f, 314, Hakdong-Ro, Gangnam-Gu Seoul KR 06098 06098
FDA Registration Numbers
- 3018302800
- 3025602618
- 3009731198
- 3023217364
- 9710602
- 3035950510
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- 3008007310
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- 3015509619
- 3016585383
- 3018094310
- 3013757696
- 3029900829
- 3004972322
- 3017233423
- 3013844297
- 8043836
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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