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Rayscan Α+ RCT700

by Ray Co., Ltd

Rayscan Α+ RCT700 is a Class II device made by Ray Co., Ltd, cleared under FDA 510(k) K182614 on 16 Oct 2018 and listed in FDA GUDID since 8 May 2020 (UDI-DI 08800003001002), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

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) K182614

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 Number08800003001002 UDI-DI Date8 May 2020ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK182614 Date16 Oct 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K182614 decided 16 Oct 2018 Active
  • FDA GUDID UDI-DI 08800003001002 listed 8 May 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K182614
  2. Listed FDA GUDID 08800003001002

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Rayscan Α+
Generic name
Stationary panoramic/tomographic dental x-ray system, digital
Model / reference
RCT700
Primary DI / UDI-DI
08800003001002
510(k) Number
FDA product code
OAS
GMDN term
Stationary panoramic/tomographic dental x-ray system, digital
Device class
Class II
Regulation number
892.1750
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K182614)

and 6 more cleared under K182614

Similar devices

Other devices filed under FDA product code OAS (X-Ray, Tomography, Computed, Dental).

Other devices from Ray Co., Ltd

See all devices from Ray Co., Ltd →

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)