# K100931: Mylabtwice, Model 6200

- Pathway: 510(k) (Traditional)
- Applicant: Esaote, S.p.A.
- Decided: Jun 25, 2010 after 81 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: 9 generations back to K924432 (1993). 67 ancestors in all.
46 later devices descend from it; 3 cite it directly.
1 of 114 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051837: Mylab 90 Ultrasound Imaging System, Model 6100, Esaote, S.p.A. (2005) Summary page 2.
- K060827: MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350, 6150, 6100, Esaote, S.p.A. (2006) Summary page 1.
- K081386: Model 6150 (MYLAB70) and Model 6100 (MYLAB90), Esaote, S.p.A. (2008) Summary page 1.

## Most influential descendants
- K133905: 6200 / 6250 Ultrasound System (2014), 34 descendants of its own
- K132466: Mylabseven 6400, Mylabalpha 7400 (2013), 22 descendants of its own
- K132231: Mylabseven, Mylabalpha (2013), 22 descendants of its own
- K161999: Aixplorer (2016), 20 descendants of its own
- K171105: AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems (2017), 19 descendants of its own

## Indications for use
Esaote's Model 6200 is a mainframe 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, lntraoperative (Abdominal), Laparoscopic and Other: Urologic. The 6200 system provides imaging for guidance of biopsy ahd imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications. 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' foll owing application: Abdominal, Musculo-skeletal, Urologic, and Vascular. The second modality image is not intended to be used as a standalone diagnostic image since it represeuits 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/K100931
Methodology: https://510kreport.com/methodology