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Smartspot Primax

by CMT Medical Technologies, Ltd.

510(k) K080890

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 · Special NumberK080890 Date29 Apr 2008ClearedStatusActive

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  • Withdrawn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, 19 Sep 2026

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

The SmartSPOT PrimaX RF is a radiography imaging system designed for high-resolution digital X-ray capture. Classified under product code LLZ, it is intended for use in diagnostic radiology procedures to produce detailed images of internal body structures for medical evaluation.

This device is supplied as a reusable medical imaging system, intended for use in radiology departments within healthcare facilities. It is regulated under 21 CFR 892.2050 and holds FDA 510(k) clearance (K080890) as substantially equivalent to a predicate device, with no third-party review. No specific sterility or MRI safety information is provided in the available data.

Similar devices

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

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