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510(k) K991535

CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS by Hitachi Medical Corp. of America — Product Code KPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1999
Date Received
May 3, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Tomography, Computed, Emission
Device Class
Class II
Regulation Number
892.1200
Review Panel
RA
Submission Type

Other clearances by Hitachi Medical Corp. of America

  • K994026 — EUB-6000 ULTRASOUND DIAGNOSTIC SCANNER (March 29, 2000)
  • K991318 — CONVERGENCE NUA FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS (June 18, 1999)
  • K991129 — HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICK NAL(TI) CRYSTAL (May 13, 1999)
  • K981434 — EUP-OL334 LAPARASCOPICPROBE (July 27, 1998)
  • K954220 — EUB-8000 (May 7, 1997)
  • K962308 — EUB-905 (July 17, 1996)
  • K954129 — SPECTRADIGITAL SERIES V250DSP (December 22, 1995)
  • K954143 — HITACHI SPECTRADIGITAL SERIES GAMMA CAMERA SYSTEMS (December 22, 1995)
  • K945400 — HITACHI DYNAMIC 3D IMAGING SYSTEM,SF-VA100 (November 20, 1995)
  • K945795 — EUB-555A+ (October 27, 1995)

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