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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K260605
Device Name Lilium one (USM330)
Applicant
Lilium Otsuka Co., Ltd.
1-1-1, Chuo Chuo-Ku
Sagamihara
Kanagawa,  JP 252-0239
Applicant Contact Yasuyo Chiba
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received02/24/2026
Decision Date 10/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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