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510(k) K832505

IMAGE PROCESSING SYS A3 by Metronic, Inc. — Product Code IYX

K832505 is an FDA 510(k) premarket notification submitted by Metronic, Inc. for the device "IMAGE PROCESSING SYS A3". The FDA issued a decision of Substantially Equivalent on September 12, 1983. The device falls under product code IYX (Camera, Scintillation (Gamma)), a Class I device regulated under 21 CFR 892.1100. Metronic, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1983
Date Received
July 27, 1983
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 Metronic, Inc.

  • K031210 — MODEL 4951M MYOCARDIAL UNIPOLAR LEAD (May 16, 2003)
  • K911827 — MODEL 5866-9M & MODEL 6981M (July 23, 1991)
  • K874884 — MEDTRONIC(R) ORTHOFLEX(TM) (January 28, 1988)

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