# K051837: Mylab 90 Ultrasound Imaging System, Model 6100

- Pathway: 510(k) (Traditional)
- Applicant: Esaote, S.p.A.
- Decided: Jul 20, 2005 after 14 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K944485 (1995). 20 ancestors in all.
64 later devices descend from it; 5 cite it directly.
0 of 85 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.
- K050326: 7350 Ultrasound Imaging System, Model 7350, Esaote, S.p.A. (2005) Summary page 1.
- K990360: AU6, Biosound Esaote, Inc. (1999) 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.
- K023255: Technos MP, Model AU6, Biosound Esaote, Inc. (2003) Summary page 1.
- K042540: Philips IU22 Ultrasound System, Philips Ultrasound, Inc. (2004) Summary page 1.

## Most influential descendants
- 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
- K081386: Model 6150 (MYLAB70) and Model 6100 (MYLAB90) (2008), 53 descendants of its own
- K091009: MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60, Model 6150 (2009), 51 descendants of its own

## Indications for use
Esaote's MyLab90 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, Adult Cephalic, Pediatric, Laparoscopic, Intraoperative: Abdominal, and Other: Urologic.

Source page: https://510kreport.com/device/K051837
Methodology: https://510kreport.com/methodology