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densitasdensity 2.x.y

by Densitas Incorporated GUDID

Listed FDA GUDID listing, not in commercial distribution

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10627843712760 UDI-DIDate7 Dec 2018ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
densitasdensity
Generic Name
Radiology DICOM image processing application software
Model / Reference
2.x.y
Primary DI / UDI-DI
10627843712760
510(k) Number
FDA Product Code
LLZ
GMDN Term
Radiology DICOM image processing application software
Device Class
Class II
Regulation Number
892.2050
GUDID distribution status
Not in Commercial Distribution

Properties

  • Prescription Use
  • Lot / Batch 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
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No