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Radialis PET Camera

by Radialis, Inc.

510(k) K214062

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 NumberK214062 Date4 Feb 2022ClearedStatusActive

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  • Withdrawn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
KPS
Device class
Class II
Regulation
21 CFR Part 892.1200
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, 1 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 Radialis PET Camera is a System, Tomography, Computed, Emission device designed for positron emission tomography (PET). It employs lutetium-containing gamma-ray detectors to capture gamma rays emitted by positron-emitting radiopharmaceuticals, enabling the generation of images that reflect the spatial distribution and concentration of radiotracers within the body. This imaging modality is primarily used in radiology for diagnostic purposes, such as oncology, neurology, and cardiology evaluations.

The device is intended for use in clinical settings where PET imaging is required, supplied as a reusable medical system. It operates under regulatory oversight in the United States, having received FDA_510K clearance under the Radiology advisory committee. The device is classified as Class II and adheres to regulatory standards outlined in 21 CFR 892.1200. No specific sterility or single-use designation is noted in the provided data.

Devices cleared under K214062

3 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 K214062
UDI-DISize and differences
RADIALIS PET CAMERA 0140
Radialis, Inc.
014000850031455016 —No longer on the market
RADIALIS PET CAMERA 133
Radialis, Inc.
0133 / 13308500314551332 —No longer on the market
RADIALIS PET IMAGER 133
Radialis, Inc.
0133 / 13300850031455337 —On the market

Similar devices

Other devices filed under FDA product code KPS (System, Tomography, Computed, Emission).

Other devices from Radialis, Inc.