K223033 — Instructions for Use (IFU)

Regulatory Update

This page summarizes key regulatory information associated with FDA 510(k) K223033 and references the Instructions for Use (IFU) document for full, authoritative guidance.

Summary (non-exhaustive): the IFU/User Manual describes intended use, safety information, setup and operation, applicable symbols, contraindications/warnings/precautions, cleaning and maintenance, troubleshooting, and technical specifications.

What this update covers:

Regulatory reference: FDA 510(k) Premarket Notification K223033.
Document type: Instructions for Use (IFU) / User Manual for the cleared system.
Operational guidance: overview of device components, preparation, operation workflow, and post-use handling.
Safety guidance: symbols, warnings/precautions, and safety-related instructions relevant to clinical use.
Maintenance: cleaning, inspection, and routine maintenance steps to support safe operation.

For the complete, authoritative instructions, attach the PDF to this page in Sanity (add a “PDF Section” and upload the IFU PDF), and treat the PDF as the source of truth.

K223033 — Instructions for Use (IFU)

Regulatory Update

This page summarizes key regulatory information associated with FDA 510(k) K223033 and references the Instructions for Use (IFU) document for full, authoritative guidance.

What this update covers:

Regulatory reference: FDA 510(k) Premarket Notification K223033.
Document type: Instructions for Use (IFU) / User Manual for the cleared system.
Operational guidance: overview of device components, preparation, operation workflow, and post-use handling.
Safety guidance: symbols, warnings/precautions, and safety-related instructions relevant to clinical use.
Maintenance: cleaning, inspection, and routine maintenance steps to support safe operation.

For the complete, authoritative instructions, attach the PDF to this page in Sanity (add a “PDF Section” and upload the IFU PDF), and treat the PDF as the source of truth.