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510(k) K905827

FULL VIEW OMEGA TABLE by Med-Tron Products, Inc. — Product Code IYX

K905827 is an FDA 510(k) premarket notification submitted by Med-Tron Products, Inc. for the device "FULL VIEW OMEGA TABLE". The FDA issued a decision of Substantially Equivalent on January 28, 1991. The device falls under product code IYX (Camera, Scintillation (Gamma)), a Class I device regulated under 21 CFR 892.1100. Med-Tron Products, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1991
Date Received
December 31, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Scintillation (Gamma)
Device Class
Class I
Regulation Number
892.1100
Review Panel
RA
Submission Type

Other clearances by Med-Tron Products, Inc.

  • K952701 — MED-TRON SPECT IMAGING TABLE (July 6, 1995)
  • K911691 — XYZ CRANK IMAGING TABLE (August 9, 1991)
  • K912181 — E-Z LIFT CRANK IMAGING TABLE (July 17, 1991)
  • K912135 — XY IMAGING TABLE (July 17, 1991)
  • K911564 — E-Z LIFT IMAGING TABLE WITH FOOT PUMP (July 15, 1991)
  • K911561 — XYZ IMAGING TABLE WITH FOOT PUMP (July 15, 1991)
  • K903988 — PANORAMIC OMEGA IMAGING TABLE (October 23, 1990)
  • K903901 — SCANNING COT (September 21, 1990)

Other clearances for product code IYX

  • K230221 — QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiot (August 28, 2023)
  • K212587 — 3D-RD-S (February 22, 2023)
  • K163687 — OLINDA EXM (July 19, 2017)
  • K160933 — Discovery NM 750b Bopsy (November 18, 2016)
  • K162052 — Sentinella 102, Sentinella 102 Horus (August 18, 2016)
  • K143156 — Sentinella 102; Sentinella 102 Horus (November 18, 2014)
  • K123408 — ERGO IMAGING SYSTEM (January 15, 2013)
  • K111791 — LUMAGEM MOLECULAR BREAST IMAGING SYSTEM (September 23, 2011)
  • K110384 — DILON 6800 ACELLA (ACELLA) (May 3, 2011)
  • K110601 — SENTINELLA 102 (March 18, 2011)

FDA data resources