Skip to content

D-Spect® 003

by Spectrum Dynamics Medical Inc. 2 variants

Listed FDA GUDID listing, not in commercial distribution

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290108670028 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: not 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  • Withdrawn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
D-Spect®
Generic Name
SPECT system, annular detector array
Model / Ref / Catalog
003, 8010018-01
Primary DI / UDI-DI
07290108670028
FDA Product Code
LLZ, KPS
GMDN Term
SPECT system, annular detector array
Device Class
Class II
Regulation Number
892.2050, 892.1200
GUDID distribution status
Not in Commercial Distribution

Other devices from Spectrum Dynamics Medical Inc.

See all devices from Spectrum Dynamics Medical Inc. →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • 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