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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K213272
Device Name Formus Hip
Applicant
Formus Labs, Ltd
Level 9 Bioengineering House 70 Symonds St., Grafton
Auckland,  NZ 1010
Applicant Contact Richie Christian
Correspondent
Formus Labs, Ltd
Level 9 Bioengineering House 70 Symonds St., Grafton
Auckland,  NZ 1010
Correspondent Contact Richie Christian
Regulation Number892.2050
Classification Product Code
QIH  
Date Received09/30/2021
Decision Date 03/31/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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