Home / 510(k) Clearances / K942346

510(k) K942346

IMAGERT by Impac Medical Systems, Inc. — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1995
Date Received
May 16, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accelerator, Linear, Medical
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

Other clearances by Impac Medical Systems, Inc.

  • K151233 — Monaco (July 7, 2015)
  • K141572 — MOSAIQ ONCOLOGY INFORMATION SYSTEM (September 5, 2014)
  • K132971 — MONACO (November 20, 2013)
  • K123230 — MOSAIQ ONCOLOGY INFORMATION SYSTEM (December 12, 2012)
  • K120067 — MOSAIQ ONCOLOGY INFORMATION SYSTEM (February 28, 2012)
  • K043412 — MODIFICATION TO: VIEWSTATION (December 20, 2004)
  • K013531 — QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00 (November 7, 2001)
  • K011694 — VIEWSTATION (August 29, 2001)
  • K991133 — MLC FIT (March 27, 2000)
  • K981313 — SEQUENCER (July 9, 1998)

Other clearances for product code IYE

  • K252977 — Halcyon, Ethos Radiotherapy System (5.0) (January 21, 2026)
  • K252188 — EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infin (January 15, 2026)
  • K254010 — ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface (January 14, 2026)
  • K252988 — ChartCheck (RADCH V1.6) (January 5, 2026)
  • K252919 — IDENTIFY (5.0) (December 16, 2025)
  • K250392 — ZAP-X Radiosurgery System (ZAP-X) (November 3, 2025)
  • K250696 — AccuCheck (October 24, 2025)
  • K250911 — MOSkin Radiation Measurement System (October 17, 2025)
  • K252948 — TrueBeam, TrueBeam STX, Edge and VitalBeam (October 7, 2025)
  • K252174 — AquaCast Mask (September 3, 2025)