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D2 Spectrum Gamma Camera/Crystal V Computer System

by Digital Design, Inc. 510(k)

Active United States

510(k) K904599

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK904599 Date23 Apr 1991ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 11 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
JWM
Device Class
Class II
Regulation
21 CFR Part 892.1310
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent