# K040596: Ultrasound Imaging System, Model 7300

- Pathway: 510(k) (Traditional)
- Applicant: Esaote, S.p.A.
- Decided: Mar 31, 2004 after 23 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K944485 (1995). 9 ancestors in all.
67 later devices descend from it; 6 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.
- K014168: AU6 (Technos/Technos MP) Ultrasound Imaging System (Addition of 3D Imaging Mode and Musculoskeletal Indication), Biosound Esaote, Inc. (2002) Summary page 1.
- K014191: M2540 Diagnostic Ultrasound System, Model M2540, Philips Medical Systems (2002) Summary page 1.

## Most influential descendants
- K050326: 7350 Ultrasound Imaging System, Model 7350 (2005), 66 descendants of its own
- 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

## 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
- May 6, 2005 · Not classified · Z-1401-05: Data may be corrupted upon re-opening archived files.
- May 6, 2005 · Not classified · Z-1403-05: Data may be corrupted upon re-opening archived files.
- May 6, 2005 · Not classified · Z-1402-05: Data may be corrupted upon re-opening archived files.

## Indications for use
Esaote's Model 7300 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal and Pediatric.

Source page: https://510kreport.com/device/K040596
Methodology: https://510kreport.com/methodology