# K081386: Model 6150 (MYLAB70) and Model 6100 (MYLAB90)

- Pathway: 510(k) (Traditional)
- Applicant: Esaote, S.p.A.
- Decided: Sep 25, 2008 after 129 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K924432 (1993). 66 ancestors in all.
53 later devices descend from it; 5 cite it directly.
1 of 120 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070106: VV Fluoro 3D, Brainlab AG (2007) Summary page 1.
- K062086: Navivision, Brainlab AG (2006) Summary page 1.
- K042391: Kolibri Image Guided Surgery System, Brainlab AG (2004) Summary page 1.
- K012564: Modification to: Vectorvision Frameless Biopsy System, Brainlab AG (2001) Summary page 1.
- K042512: Vectorvision Acl, Brainlab AG (2005) Summary page 1.
- K051308: Mylab 70 Ultrasound Imaging System, Esaote, S.p.A. (2005) Summary page 1.
- K051837: Mylab 90 Ultrasound Imaging System, Model 6100, 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.
- K013722: Modification to: Eub-8500 Diagnostic Ultrasound Scanner, Hitachi Medical Corp. (2002) Summary page 1.

## Most influential descendants
- K091009: MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60, Model 6150 (2009), 51 descendants of its own
- K100931: Mylabtwice, Model 6200 (2010), 46 descendants of its own
- K103152: 6250 Ultrasound Sytems (2011), 35 descendants of its own
- K133905: 6200 / 6250 Ultrasound System (2014), 34 descendants of its own
- K110688: Mylabgold (2011), 25 descendants of its own

## Recalls of this device
- Jan 3, 2018 · Class II · Z-1138-2018: The ultrasound system used in certain settings may result in overheating of the ultrasound probe head.
- Jan 3, 2018 · Class II · Z-1137-2018: The ultrasound system used in certain settings may result in overheating of the ultrasound probe head.

## Indications for use
Esaote's Model 6150 (MyLab7O) and Model 6100 (MyLab9O) are mainframe ultrasound systems 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. Additionally, the MyLab9O is indicated for Laparoscopic use. The Virtual Navigator is a MyLab optional license that provides additional image information from a second modality like CT or MR, during a clinical ultrasound session. The second modality provides additional security in assessing the morphology of the ultrasound image. Virtual Navigator can be used in the following application: Abdominal, Musculo-skeletal, Urologic, and Vascular. The second modality image is not intended to be used as a standalone diagnostic image since it represents information of a patient that could not be congruent with the current (actual) patient position and shall therefore always been seen as an additional source of information. The Virtual Navigator tracking system should not be used on or around persons with a cardiac pacemaker, and should not be used around life supporting equipment.

Source page: https://510kreport.com/device/K081386
Methodology: https://510kreport.com/methodology