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510(k) K082588

GAMMALOC SYSTEM, MODEL 03-00001 by Dilon Technologies, LLC — Product Code IYX

K082588 is an FDA 510(k) premarket notification submitted by Dilon Technologies, LLC for the device "GAMMALOC SYSTEM, MODEL 03-00001". The FDA issued a decision of Substantially Equivalent on December 11, 2009. The device falls under product code IYX (Camera, Scintillation (Gamma)), a Class I device regulated under 21 CFR 892.1100. Dilon Technologies, LLC has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 2009
Date Received
September 8, 2008
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 Dilon Technologies, LLC

  • K110384 — DILON 6800 ACELLA (ACELLA) (May 3, 2011)
  • K984466 — DILON 2000, MODEL 2000-6X8 AND DILON 2000, MODEL 2000-5X5 (March 16, 1999)

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