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RAYSCAN α-Expert Pano(Pluto0600X)

by Ray Co., Ltd

RAYSCAN α-Expert Pano(Pluto0600X) is a Class II device made by Ray Co., Ltd, cleared under FDA 510(k) K232325 on 18 Apr 2024 and listed in FDA GUDID since 26 Apr 2024 (UDI-DI 08800003000265), 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) K232325

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 Number08800003000265 UDI-DI Date26 Apr 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK232325 Date18 Apr 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K232325 decided 18 Apr 2024 Active
  • FDA GUDID UDI-DI 08800003000265 listed 26 Apr 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K232325
  2. Listed FDA GUDID 08800003000265

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  • Withdrawn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-Expert
Generic name
Stationary panoramic/tomographic dental x-ray system, digital
Model / reference
Pano(Pluto0600X)
Primary DI / UDI-DI
08800003000265
510(k) Number
FDA product code
MUH
GMDN term
Stationary panoramic/tomographic dental x-ray system, digital
Device class
Class II
Regulation number
872.1800
GUDID distribution status
In Commercial Distribution

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Properties

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