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DBx 1.4

by Mirada Medical, Ltd.

DBx 1.4 is a medical device (FDA Class I; FDA product code OUG, Medical Device Data System) made by Mirada Medical, Ltd., listed in FDA GUDID since 8 Oct 2020 (UDI-DI B334DBX1P40), registry data as of 23 Oct 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB334DBX1P40 UDI-DI Date8 Oct 2020ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
DBx
Generic name
Radiology picture archiving and communication system workstation
Model / reference
1.4
Primary DI / UDI-DI
B334DBX1P40
FDA product code
OUG
GMDN term
Radiology picture archiving and communication system workstation
Device class
Class I
Regulation number
880.6310
GUDID distribution status
In Commercial Distribution

Related devices

Category: Radiology picture archiving and communication system workstation

Similar devices in this category

Other devices filed under Radiology picture archiving and communication system workstation.

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Properties

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