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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: BONZAI; CT MINI; Djinn Beetle; Djinn Mammo; Djinn Tonix; DMR; GAIA INTERVENTIONAL GENERATOR; Jedi; Jedi 100 VASC 1; JEDI 100 VASC 1T; Jedi 42 CT; Jedi 50 Plus R1T; Jedi 50 R 1T; Jedi 60 CT; Jedi 60 DC; JEDI 60 DC LITE; Jedi 60DC; Jedi 60DC Lite; Jedi 80 R 1T; Jedi 80 RD 1T; Jedi 80 RF 1T; Jedi 80 RF 2T; JEDI 80 RF1T; JEDI HP; Jedi NP+V1.5; JEDI SC FAST kV; JEDI VCT; Jedi42CT; Jedi50R1T; Jedi60CT; Jedi80R1T; Jedi80RF1T; Jedi80RF2T; MPG100; MPG50; MPPU; Prisme; Prodigy/DPX Series High Voltage Power Supply; SYJ; TTH; TTH 8800; TTH HAWKEYE; TTH MAESTRO; VAMP; VMX; X-Ray Generator; ZEUS; ZEUS, ZJ/QJ; ZJ/QJ; Zyx
Classification Name: GENERATOR, HIGH-VOLTAGE, X-RAY, DIAGNOSTIC
Product Code: IZO
Device Class: 1
Regulation Number: 892.1700
Medical Specialty: Radiology
Registered Establishment Name: GE Medical Systems Ultrasound & Primary Care Diagnostics LLC
Registered Establishment Number: 2183066
Owner/Operator: GE HealthCare Technologies Inc.
Owner/Operator Number: 9912004
Establishment Operations: Specification Developer
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