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AcuityPDR Standard

by Radmedix, LLC 24 variants

AcuityPDR Standard is a portable basic diagnostic x-ray system (FDA Class II; FDA product code IZL, System, X-Ray, Mobile) made by Radmedix, LLC, cleared under FDA 510(k) K200726 on 13 Apr 2020 and listed in FDA GUDID since 4 Jun 2020 (UDI-DI 00810035220348), 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 Number00810035220348 UDI-DI Date4 Jun 2020ListedStatusListed 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 00810035220348 listed 4 Jun 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K200726
  2. Listed FDA GUDID 00810035220348

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
AcuityPDR
Generic name
Portable basic diagnostic x-ray system, digital
Model / reference
Standard
Primary DI / UDI-DI
00810035220348
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
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)