Home / 510(k) Clearances / K011290

510(k) K011290

PROGNOST ES, MODEL 0302 0000 by Xmar Corp. — Product Code IZF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 2001
Date Received
April 27, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomographic
Device Class
Class II
Regulation Number
892.1740
Review Panel
RA
Submission Type

Other clearances for product code IZF

  • K252649 — TAP2D (February 2, 2026)
  • K252133 — Adaptix Ortho350 (November 6, 2025)
  • K250850 — Nanox.ARC X (April 16, 2025)
  • K242395 — Nanox.ARC (December 4, 2024)
  • K222934 — Nanox.ARC (April 28, 2023)
  • K221949 — Ortho Device, ADAPTIX 3D Orthopedic Imaging System (January 26, 2023)
  • K213081 — CLISIS SYSTEMS, Discovery RF180 (October 26, 2021)
  • K193262 — DR 600 with Tomosynthesis (March 9, 2020)
  • K183275 — DR 800 with Tomosynthesis (February 1, 2019)
  • K132261 — DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS) (November 18, 2013)