Skip to content

HAD1717MC

by H&Abyz

510(k) K200018

HAD1717MC is a Class II device made by H&Abyz, cleared under FDA 510(k) K200018 on 31 Jan 2020, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK200018 Date31 Jan 2020ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
MQB
Device class
Class II
Regulation
21 CFR Part 892.1680
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Devices cleared under K200018

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K200018
UDI-DISize and differences
HAD1717MC
H&abyz Co., Ltd.
HAD1717MC08800070400012 —On the market

Similar devices

Other devices filed under FDA product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)).

Other devices from H&abyz Co., Ltd.

  • Add HAD1417MCW

    Class II

  • A1417MCW

    Class II

  • A1717MCW

    Class II

  • HAD1717MC

    Class II

See all devices from H&abyz Co., Ltd. →