Ultrasound System Sonimage HS1, Linear Probe L18-4, Convex Probe C5-2
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K142197 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 Sonimage HS1 is a point-of-care portable ultrasound system designed to support a wide range of applications and patient types. It delivers advanced technologies to ensure excellent image quality and efficient workflow.
The system is supplied as a complete unit with two probes: the L18-4 linear probe and the C5-2 convex probe. It is intended for single-use applications and is not reusable. The device is not MRI safe and should be stored in a dry environment.
Frequently asked questions
What is the Sonimage HS1 ultrasound system?
The Sonimage HS1 is a portable point-of-care ultrasound system designed to support a wide range of applications and patient types. It is supplied as a complete unit with two probes.
What probes are included with the Sonimage HS1?
The system is supplied with two probes: the L18-4 linear probe and the C5-2 convex probe.
Is the Sonimage HS1 reusable?
No, the Sonimage HS1 is intended for single-use applications and is not reusable.
How should the Sonimage HS1 be stored?
The device should be stored in a dry environment.
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: PDF Konica Minolta, Inc., PDF HS1 Compact Ultrasound System - Konica Minolta Healthcare Americas, Inc., Konica Minolta SONOIMAGE HS1 Ultrasound For Sale | UDS, PDF HS1_Catalog4 - medica.konicaminolta.eu
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142197 | Class II | Active |
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Manufacturer
- Manufacturer
- Konica Minolta, Inc.
Sources (1)
- FDA 510(k) K142197 24 fields · synced Sep 27, 2026