Skip to content

Foresee (4C) Imaging System

by Diagnostic Photonics, Inc. 510(k)

Active United States

510(k) K133209

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK133209 Date17 Mar 2014ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
NQQ
Device Class
Class II
Regulation
21 CFR Part 892.1560
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Foresee (4C) Imaging System is an optical coherence tomography imaging tool designed for the evaluation of external human tissue microstructure. It provides two-dimensional, cross-sectional, real-time depth visualization of tissue structures.

This system has received FDA 510(k) clearance. It is designed to comply with international standards for electrical and mechanical safety, electromagnetic compatibility, biocompatibility, disinfection, and laser safety.

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary clinical use of the Foresee (4C) Imaging System?

    The Foresee (4C) Imaging System is an optical coherence tomography tool used for the evaluation of external human tissue microstructure. It provides real-time, two-dimensional, cross-sectional visualization of tissue structures to assist in clinical assessment.

  • What is the regulatory status of the Foresee (4C) Imaging System?

    The system has received FDA 510(k) clearance, which indicates that it has been determined to be substantially equivalent to legally marketed predicate devices. It is classified as a Class 2 medical device under regulation number 892.1560.

  • What safety standards does the Foresee (4C) Imaging System meet?

    The device is designed to comply with international standards for electrical and mechanical safety, electromagnetic compatibility, biocompatibility, disinfection, and laser safety to ensure it meets established performance requirements for clinical environments.