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Planmeca Viso G5

by Planmeca Oy

Planmeca Viso G5 (30016183) is a Class II device made by Planmeca Oy, cleared under FDA 510(k) K181576 on 13 Sep 2018 and listed in FDA GUDID since 6 Mar 2019 (UDI-DI 06430035420605), active as of 22 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 22 Oct 2026

Documents

510(k) K181576

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06430035420605 UDI-DI Date6 Mar 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK181576 Date13 Sep 2018IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K181576 decided 13 Sep 2018 Active
  • FDA GUDID UDI-DI 06430035420605 listed 6 Mar 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K181576
  2. Listed FDA GUDID 06430035420605

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Planmeca Viso
Generic name
Stationary panoramic/tomographic dental x-ray system, digital
Model / Ref / Catalog
G5, 30016183
Primary DI / UDI-DI
06430035420605
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
In Commercial Distribution

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Properties

  • Prescription use
  • Over-the-counter
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)