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GE Healthcare · Nuclear MedicineInfinia

Do we have to submit FDA Form 2579 when we do an X-Ray Tube change on the Infinia Hawkeye and Infinia Hawkeye 4

Symptom

Do we have to submit FDA Form 2579 when we do an X-Ray Tube change on the Infinia Hawkeye and Infinia Hawkeye 4 Do we have to submit FDA Form 2579 when we do an X-Ray Tube change on the Infinia Hawkeye and Infinia Hawkeye 4?

Applies to

Models
Infinia
Product
Infinia II Infinia II Acquisition System Infinia HE4 Infinia II Hawkeye 4 & Infinia II GP (Infinia running Windows XP software) Infinia I Infinia I Acquisition System VGH VG and VG Hawkey and Varicam
Component
*X-Ray (Generator, DAS, Controller) *X-Ray (Generator, DAS, Controller)
Area
Nuclear Medicine

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