← Back to catalogue

TECHFIT Diagnostic Models

FDA 510(k)

Class II (US FDA 510(k))

510(k) K222577

by Techfit Digital Surgery, Inc.

Identifiers

510(k) Number
K222577 FDA 510(k)
FDA Product Code
LLZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.2050 FDA 510(k)
Regulation Number
892.2050 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

TECHFIT Diagnostic Models are medical devices used for diagnostic purposes in radiology applications. These models are designed to assist in medical imaging procedures and diagnostic assessments.

The TECHFIT Diagnostic Models are supplied by Techfit Digital Surgery, Inc. and have received FDA 510K clearance with K number K222577. The devices are regulated under product code LLZ and were cleared as substantially equivalent on January 6, 2023.

Frequently asked questions

What are TECHFIT Diagnostic Models used for?

TECHFIT Diagnostic Models are medical devices specifically designed for diagnostic purposes in radiology applications. They assist healthcare professionals in medical imaging procedures and diagnostic assessments to support accurate patient evaluation.

How are TECHFIT Diagnostic Models supplied?

TECHFIT Diagnostic Models are supplied by Techfit Digital Surgery, Inc. The company is located at 1511 Aviation Center Pkwy., Suite 220h, Daytona Beach, FL 32114, with David Garcia-Patino as the contact person.

What is the regulatory status of TECHFIT Diagnostic Models?

TECHFIT Diagnostic Models have received FDA 510K clearance with K number K222577. They were cleared as substantially equivalent on January 6, 2023, and are regulated under product code LLZ by the Radiology Advisory Committee.

Are there different sizes or models available for TECHFIT Diagnostic Models?

The device data does not specify different sizes or models for TECHFIT Diagnostic Models. The information provided indicates a single device type designed for general diagnostic purposes in radiology applications.

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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Techfit Digital Surgery, Inc.

Sources (1)

  • FDA 510(k) K222577 24 fields · synced Sep 23, 2026