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Exprimer EVS 3643AG

by Drtech Corp.

Exprimer EVS 3643AG is a Class II device made by Drtech Corp., cleared under FDA 510(k) K192400 on 3 Oct 2019 and listed in FDA GUDID since 28 Oct 2019 (UDI-DI 08800018405703), 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) K192400

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 Number08800018405703 UDI-DI Date28 Oct 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK192400 Date3 Oct 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K192400 decided 3 Oct 2019 Active
  • FDA GUDID UDI-DI 08800018405703 listed 28 Oct 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K192400
  2. Listed FDA GUDID 08800018405703

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Exprimer
Generic name
Indirect flat panel x-ray detector
Model / reference
EVS 3643AG
Primary DI / UDI-DI
08800018405703
510(k) Number
FDA product code
MQB
GMDN term
Indirect flat panel x-ray detector
Device class
Class II
Regulation number
892.1680
GUDID distribution status
In Commercial Distribution

Related devices

Category: Indirect flat panel x-ray detector

Cleared under the same submission (K192400)

Similar devices in this category

Other devices filed under Indirect flat panel x-ray detector.

Other devices from Drtech Corp.

See all devices from Drtech Corp. →

Properties

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