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RIOScan IP Size 1

by Ray Co., Ltd

RIOScan IP Size 1 is a Class II device made by Ray Co., Ltd, cleared under FDA 510(k) K160788 on 15 Apr 2016 and listed in FDA GUDID since 5 Oct 2016 (UDI-DI 08800003003327), 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) K160788

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 Number08800003003327 UDI-DI Date5 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK160788 Date15 Apr 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K160788 decided 15 Apr 2016 Active
  • FDA GUDID UDI-DI 08800003003327 listed 5 Oct 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K160788
  2. Listed FDA GUDID 08800003003327

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
RIOScan
Generic name
Dental computed radiography digital imaging scanner
Model / reference
IP Size 1
Primary DI / UDI-DI
08800003003327
510(k) Number
FDA product code
MUH
GMDN term
Dental computed radiography digital imaging scanner
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)