# K110202: Fujifilm Diagnostic Ultrasound System Fazone CB

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical System U.S.A., Inc.
- Decided: Feb 8, 2011 after 15 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) ZONARE z.one Ultra Ultrasound System: named in the summary without a submission number

## Indications for use
The system is intended for use by a qualified physician for ultrasound evaluation of Fetal/obstetric, gynecological, Abdominal (renal, GYN/Pelvic), Pediatric, Small organ (thyroid, breast, testes, etc), Adult & Neonatal Cephalic, Trans-vaginal, Trans-cranial, Musculoskeletal (conventional & superficial), Cardiac-AdultiPediatric/Fetal, Pelvic, Peripheral vascular, and harmonic tissue.

Source page: https://510kreport.com/device/K110202
Methodology: https://510kreport.com/methodology