Acuity DX+ 1

by Radmedix, LLC

Acuity DX+ 1 is a Class II device made by Radmedix, LLC, cleared under FDA 510(k) K223010 on 17 Jan 2023 and listed in FDA GUDID since 11 Apr 2025 (UDI-DI 00810035220539), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00810035220539 UDI-DI	Date11 Apr 2025Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK223010	Date17 Jan 2023Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00810035220539
FDA 510(k) database 510(k) number K223010

Across registries

2 registries list this device

FDA 510(k) K223010 decided 17 Jan 2023 Active
FDA GUDID UDI-DI 00810035220539 listed 11 Apr 2025 Listed

Timeline

2 dated events

17 Jan 2023 Cleared FDA 510(k) K223010
11 Apr 2025 Listed FDA GUDID 00810035220539

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Acuity DX+
Generic name: Hand-held intraoral dental x-ray system, digital
Model / reference: 1

Primary DI / UDI-DI: 00810035220539
510(k) Number: K223010
FDA product code: EHD
GMDN term: Hand-held intraoral dental x-ray system, digital

Device class: Class II
Regulation number: 872.1800
GUDID distribution status: In Commercial Distribution

Sterilisation method: Liquid Chemical

Similar devices in this category

Other devices filed under Hand-held intraoral dental x-ray system, digital.

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)