Home / 510(k) Clearances / K875378

510(k) K875378

SINGLE PHOTON SET 031 & AZ-701-NTS-SP EMISSION by Shimadzu Precision Instruments, Inc. — Product Code KPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1988
Date Received
December 31, 1987
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 Shimadzu Precision Instruments, Inc.

  • K940294 — SHIMADZU MOBILE X-RAY SYSTEMS (March 16, 1994)
  • K890913 — SDU 800 DIAGNOSTIC ULTRASOUND INSTRUMENT (September 6, 1989)
  • K884598 — SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-1200 (April 20, 1989)
  • K884477 — SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150B (March 15, 1989)
  • K882311 — SHIMADZU LATERAL C-ARM MH-31 (September 14, 1988)
  • K881674 — SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TC (September 2, 1988)
  • K874910 — SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-200 (July 1, 1988)
  • K881795 — SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150K (July 1, 1988)
  • K875370 — SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TX (May 18, 1988)
  • K874946 — SHIMADZU X-RAY HIGH VOLTAGE GENERATOR HD150G-60 (March 3, 1988)

Other clearances for product code KPS

  • K253564 — uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo (February 13, 2026)
  • K254001 — VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 4 (January 13, 2026)
  • K253844 — AnyScan 3.0 NM Scanner Family (December 30, 2025)
  • K251370 — Cartesion Prime (PCD-1000A/3) V10.21 (December 1, 2025)
  • K251401 — PennPET Explorer Positron Emission Tomograph (November 25, 2025)
  • K252477 — Hybrid Viewer (00859873006240) (September 9, 2025)
  • K250170 — PHAROS (August 15, 2025)
  • K251561 — Biograph Trinion (July 31, 2025)
  • K251839 — uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) (July 17, 2025)
  • K251671 — Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems (July 3, 2025)