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510(k) K991129

HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICK NAL(TI) CRYSTAL by Hitachi Medical Corp. of America — Product Code KPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 1999
Date Received
April 2, 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)
  • K991535 — CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS (July 30, 1999)
  • K991318 — CONVERGENCE NUA FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS (June 18, 1999)
  • K981434 — EUP-OL334 LAPARASCOPICPROBE (July 27, 1998)
  • K954220 — EUB-8000 (May 7, 1997)
  • K962308 — EUB-905 (July 17, 1996)
  • K954143 — HITACHI SPECTRADIGITAL SERIES GAMMA CAMERA SYSTEMS (December 22, 1995)
  • K954129 — SPECTRADIGITAL SERIES V250DSP (December 22, 1995)
  • K945400 — HITACHI DYNAMIC 3D IMAGING SYSTEM,SF-VA100 (November 20, 1995)
  • K945795 — EUB-555A+ (October 27, 1995)

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