# K050326: 7350 Ultrasound Imaging System, Model 7350

- Pathway: 510(k) (Traditional)
- Applicant: Esaote, S.p.A.
- Decided: Feb 28, 2005 after 19 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K944485 (1995). 10 ancestors in all.
66 later devices descend from it; 5 cite it directly.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982444: 7250 Ultrasound Imaging System, Biosound Esaote, Inc. (1998) Summary page 1.
- K994369: 7250 (MEGAS), Biosound Esaote, Inc. (2000) Summary page 1.
- K040596: Ultrasound Imaging System, Model 7300, Esaote, S.p.A. (2004) Summary page 1.

## Most influential descendants
- K051837: Mylab 90 Ultrasound Imaging System, Model 6100 (2005), 64 descendants of its own
- K051308: Mylab 70 Ultrasound Imaging System (2005), 64 descendants of its own
- K060827: MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350, 6150, 6100 (2006), 62 descendants of its own
- K052805: MYLAB30, 50 and 70 Systems Upgrade, Models 7300, 7350, 6150 (2005), 60 descendants of its own
- K081794: Model 7340 Ultrasound System (2008), 57 descendants of its own

## Recalls of this device
- Jun 26, 2014 · Class II · Z-2167-2014: Using the PA230E transducer with a user-defined setting with the output power to 100% (Max) in 2D-TEI mode focusing at maximum depth, could cause the transducer surface temperature to exceed the maxim

## Indications for use
Esaote's Model 7350 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal and Pediatric.

Source page: https://510kreport.com/device/K050326
Methodology: https://510kreport.com/methodology