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DTX Studio™ Core 3.10

by Nobel Biocare AB

DTX Studio™ Core 3.10 (300547) is a Class I device made by Nobel Biocare AB, listed in FDA GUDID since 21 Apr 2021 (UDI-DI 07332747185102), registry data as of 12 Nov 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07332747185102 UDI-DI Date21 Apr 2021ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
DTX Studio™ Core
Generic name
Radiology picture archiving and communication system digital archive device
Model / Ref / Catalog
3.10, 300547
Primary DI / UDI-DI
07332747185102
FDA product code
OUG
GMDN term
Radiology picture archiving and communication system digital archive device
Device class
Class I
Regulation number
880.6310
GUDID distribution status
In Commercial Distribution

Related devices

Category: Radiology picture archiving and communication system digital archive device

Similar devices

Other devices filed under FDA product code OUG (Medical device data system).

Other devices from Nobel Biocare AB

See all devices from Nobel Biocare AB →

Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)