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TECHFIT Diagnostic Models

by Techfit Digital Surgery, Inc.

510(k) K222577

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK222577 Date6 Jan 2023ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

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

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 23 Sep 2026

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

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.

Devices cleared under K222577

8 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K222577
UDI-DISize and differences
TECHFIT 0
Techfit Digital Surgery, Inc.
MAP3DD / 000860011469292 —No longer on the market
TECHFIT 0
Techfit Digital Surgery, Inc.
MAPCC / 000860014930942 —No longer on the market
TECHFIT 0
Techfit Digital Surgery, Inc.
MAPCDCL / 000860014930935 —No longer on the market
TECHFIT 0
Techfit Digital Surgery, Inc.
MAPMANI / 000860011469247 —No longer on the market
TECHFIT 0
Techfit Digital Surgery, Inc.
MAPMANI2P / 000860010801697 —No longer on the market
TECHFIT 0
Techfit Digital Surgery, Inc.
MAPMANIFZD / 000860011469209 —No longer on the market
TECHFIT 0
Techfit Digital Surgery, Inc.
MAPMAXI / 000860011469254 —No longer on the market
TECHFIT 0
Techfit Digital Surgery, Inc.
MAPMMCL / 000860007543432 —No longer on the market

Similar devices

Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).

Other devices from Techfit Digital Surgery, Inc.