Skip to content

Lumos 3DX Intraoral Sensor VBS-1008

by Valkyrie BioScience, Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860009570115 UDI-DI Date13 Sep 2026ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Lumos 3DX Intraoral Sensor
Generic Name
Mobile basic diagnostic x-ray system, digital
Model / Reference
VBS-1008
Primary DI / UDI-DI
00860009570115
510(k) Number
FDA Product Code
EHD
GMDN Term
Mobile basic diagnostic x-ray system, digital
Device Class
Class II
Regulation Number
872.1800
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Properties

  • Prescription Use
  • Serial Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No