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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: 11L-D; 12S-D; 6S-D; 9L-D; C1-6-D; C2-9-D; eM6C G3; IC5-9-D; L8-18i-D; M5Sc-D; ML6-15-D; RAB6-D; RIC10-D; RIC5-9-D; RIC6-12-D; RM6C; RM7C; RSP6-16-D; Voluson Expert 18; Voluson Expert 20; Voluson Expert 22
Classification Name: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
Product Code: ITX
Device Class: 2
Regulation Number: 892.1570
Medical Specialty: Radiology
Registered Establishment Name: PARALLEL DESIGN SAS
Registered Establishment Number: 3003594449
Premarket Submission Number: K220358
Owner/Operator: GE HealthCare Technologies Inc.
Owner/Operator Number: 9912004
Establishment Operations: Specification Developer
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