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SubtleREFORMAT (1.x)

by Subtle Medical, Inc. United States 510(k)

510(k) K233699

Product code LLZ

Overview

SubtleREFORMAT (1.x) is a software device that has been determined to be substantially equivalent to a predicate device through the FDA 510(k) clearance process. It is classified under the Radiology advisory committee and assigned product code LLZ.

The device was submitted by Subtle Medical, Inc. and received FDA clearance on April 29, 2024, under traditional 510(k) review. It is identified by K-number K233699 and was developed by the applicant located in Menlo Park, California.

Summary written by AI from registry data, 23 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically 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.

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK233699 Date29 Apr 2024ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Other devices from Subtle Medical, Inc.

See all devices from Subtle Medical, Inc. →

Questions

  • What is SubtleREFORMAT (1.x) used for?

    SubtleREFORMAT (1.x) is a software device that has been determined to be substantially equivalent to a predicate device through the FDA 510(k) clearance process, indicating it performs similarly to a legally marketed device in the Radiology specialty.

  • How was SubtleREFORMAT (1.x) cleared for use?

    SubtleREFORMAT (1.x) received FDA clearance on April 29, 2024, under the traditional 510(k) review pathway, meaning it was found substantially equivalent to a legally marketed predicate device based on submitted data.

  • What regulatory classification applies to SubtleREFORMAT (1.x)?

    SubtleREFORMAT (1.x) is classified under the Radiology advisory committee and assigned product code LLZ, which helps identify its device type and intended use within the FDA’s product classification system.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K233699 24 fields · synced 22 Oct 2026