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Aidia Rmf-2000

by Drtech Corp.

Aidia Rmf-2000 is a Class II device made by Drtech Corp., cleared under FDA 510(k) K220073 on 26 Jan 2023 and listed in FDA GUDID since 15 Jun 2023 (UDI-DI 08800018423004), active as of 23 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 23 Oct 2026

Documents

510(k) K220073

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800018423004 UDI-DI Date15 Jun 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK220073 Date26 Jan 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K220073 decided 26 Jan 2023 Active
  • FDA GUDID UDI-DI 08800018423004 listed 15 Jun 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K220073
  2. Listed FDA GUDID 08800018423004

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Aidia
Generic name
Stationary mammographic x-ray system, digital
Model / reference
RMF-2000
Primary DI / UDI-DI
08800018423004
510(k) Number
FDA product code
MUE
GMDN term
Stationary mammographic x-ray system, digital
Device class
Class II
Regulation number
892.1715
GUDID distribution status
In Commercial Distribution

Related devices

Category: Stationary mammographic x-ray system, digital

Other devices from Drtech Corp.

See all devices from Drtech Corp. →

Properties

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