Identifiers
- 510(k) Number
- K162583 FDA 510(k)
- FDA Product Code
- IYN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1550 FDA 510(k)
- Regulation Number
- 892.1550 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Aloka Lisendo 880 is a diagnostic ultrasound system used by clinicians in clinical settings. It utilizes ultrasound transducers to transmit energy into the body and detect reflected echoes.
The device is supplied as a complete ultrasound system and is intended for use in various clinical settings. It is a reusable device that has received FDA 510(k) clearance with product code IYN and is manufactured by Hitachi, Ltd.
Frequently asked questions
What is the Aloka Lisendo 880 used for?
The Aloka Lisendo 880 is a diagnostic ultrasound system used by clinicians in clinical settings. It utilizes ultrasound transducers to transmit energy into the body and detect reflected echoes for diagnostic purposes.
How is the Aloka Lisendo 880 supplied?
The device is supplied as a complete ultrasound system, including all necessary components for diagnostic ultrasound imaging in various clinical environments.
Is the Aloka Lisendo 880 a single-use or reusable device?
The Aloka Lisendo 880 is a reusable device designed for multiple diagnostic examinations in clinical settings, provided it is properly maintained and sterilized according to manufacturer guidelines.
What regulatory approvals does the Aloka Lisendo 880 have?
The Aloka Lisendo 880 has received FDA 510(k) clearance with product code IYN, classified as substantially equivalent to predicate devices, and was reviewed by the Radiology advisory committee.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ALOKA LISENDO 880 (K162583) — FDA 510 (k) | Innolitics, Hitachi Aloka - LISENDO 880 - MedWrench, PDF Redefining the Vision for Cardiovascular Ultrasound, Hitachi Healthcare Americas introduces the "LISENDO 880," New Premium ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K162583 | Class II | Active |
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Manufacturer
- Manufacturer
- Hitachi, Ltd.
- FDA Applicant
- Hitachi , Ltd.
Sources (1)
- FDA 510(k) K162583 24 fields · synced Sep 24, 2026