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Radialis Pet Camera 0140

by Radialis, Inc.

Radialis Pet Camera 0140 is a Class II device made by Radialis, Inc., cleared under FDA 510(k) K214062 on 4 Feb 2022 and listed in FDA GUDID since 7 Feb 2025 (UDI-DI 00850031455016), active (FDA 510(k)), not in commercial distribution (GUDID) as of 22 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K214062

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850031455016 UDI-DI Date7 Feb 2025ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK214062 Date4 Feb 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K214062 decided 4 Feb 2022 Active
  • FDA GUDID UDI-DI 00850031455016 listed 7 Feb 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K214062
  2. Listed FDA GUDID 00850031455016

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Radialis Pet Camera
Generic name
PET system
Model / reference
0140
Primary DI / UDI-DI
00850031455016
510(k) Number
FDA product code
KPS
GMDN term
PET system
Device class
Class II
Regulation number
892.1200
GUDID distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: PET system

Cleared under the same submission (K214062)

Similar devices

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

Other devices from Radialis, Inc.

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)