7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)
K-Number: K253310 · 2025-11-25
Device Summary
Frequently Asked Questions
What is the 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)?
7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30) is a medical device that received FDA 510(k) clearance on 2025-11-25. The listed applicant is Esaote, S.p.A.. The 510(k) number is K253310.
When did 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30) receive FDA 510(k) clearance?
7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30) received FDA 510(k) clearance on 2025-11-25, under 510(k) number K253310.
Who is the listed applicant for 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)?
The FDA 510(k) record lists Esaote, S.p.A. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)?
The FDA product code for 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30) is IYN.
Other records listing Esaote, S.p.A. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: IYN)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.