# K071996: MYLAB30, Model 7300

- Pathway: 510(k) (Traditional)
- Applicant: Esaote, S.p.A.
- Decided: Aug 3, 2007 after 8 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K944485 (1995). 62 ancestors in all.
No later device cites it as a predicate yet.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040596: Ultrasound Imaging System, Model 7300, Esaote, S.p.A. (2004) Summary page 1.
- K052805: MYLAB30, 50 and 70 Systems Upgrade, Models 7300, 7350, 6150, Esaote, S.p.A. (2005) Summary page 1.
- K060827: MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350, 6150, 6100, Esaote, S.p.A. (2006) Summary page 1.
- K033367: Titan Ultrasound System, Sonosite Ilook 25 Ultrasound System, 180PLUS Ultrasound System, Model L03073, L02245, L02464, Sonosite,Inc. (2003) Summary page 1.

## Indications for use
Esaote's Model 7300 (MyLab3O) 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, Pediatric, Intraoperative: Abdominal, and Other: Urologic. The system provides imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

Source page: https://510kreport.com/device/K071996
Methodology: https://510kreport.com/methodology