Home / 510(k) Clearances / K041840

510(k) K041840

MEDX NUQUEST - INTECAM SPECT 37-75 SYSTEM by Medx, Inc. — Product Code KPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 2004
Date Received
July 8, 2004
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 Medx, Inc.

  • K082581 — C-QUEST (November 14, 2008)
  • K073456 — T-QUEST SYSTEM (December 20, 2007)
  • K012953 — GIOTTO IMAGE (November 30, 2001)
  • K993893 — MEDX INTECAM INTERFACE (February 10, 2000)
  • K911666 — MEDX MACHINE (July 3, 1991)
  • K896553 — MEDX CERVICAL EXTENSION TEST & REHAB MACHINE (January 2, 1990)
  • K895236 — MEDX REHABILITATION MACHINE (September 14, 1989)
  • K884661 — D-SCOPE III (April 12, 1989)
  • K872127 — D-SCOPE II AND D-SCOPE IIC (June 18, 1987)
  • K870703 — SKAN D-SCOPE (February 26, 1987)

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)