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Radmedix AcuityPDR+ 1

by Radmedix, LLC

Radmedix AcuityPDR+ 1 is a Class II device made by Radmedix, LLC, cleared under FDA 510(k) K200726 on 13 Apr 2020 and listed in FDA GUDID since 29 Nov 2021 (UDI-DI 00810035220461), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

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) K200726

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 Number00810035220461 UDI-DI Date29 Nov 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK200726 Date13 Apr 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K200726 decided 13 Apr 2020 Active
  • FDA GUDID UDI-DI 00810035220461 listed 29 Nov 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K200726
  2. Listed FDA GUDID 00810035220461

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Radmedix AcuityPDR+
Generic name
Portable basic diagnostic x-ray system, digital
Model / reference
1
Primary DI / UDI-DI
00810035220461
510(k) Number
FDA product code
IZL
GMDN term
Portable basic diagnostic x-ray system, digital
Device class
Class II
Regulation number
892.1720
GUDID distribution status
In Commercial Distribution
Sterilisation method
Liquid Chemical

Related devices

Category: Portable basic diagnostic x-ray system, digital

Cleared under the same submission (K200726)

and 8 more cleared under K200726

Similar devices

Other devices filed under FDA product code IZL (System, X-Ray, Mobile).

Other devices from Radmedix, LLC

See all devices from Radmedix, LLC →

Properties

  • Sterilise before use
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)