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Millcomp

by Math Resolutions, LLC

510(k) K011845

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.

Overview

MILLCOMP is a high-precision radiation registration device designed for accurate and reliable medical imaging, particularly in radiology. This device features advanced technology, including linear accelerators, to provide precise measurement of patient anatomy. Its accuracy and reliability have been consistently demonstrated through various clinical trials and studies.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK011845 Date4 Dec 2001ClearedStatusActive

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  • Withdrawn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
IYE
Device class
Class II
Regulation
21 CFR Part 892.5050
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Devices cleared under K011845

1 device · 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 K011845
UDI-DISize and differences
MillComp 1
MATH RESOLUTIONS, LLC
1B229MC11 —On the market

Similar devices

Other devices filed under FDA product code IYE (Accelerator, Linear, Medical).

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