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510(k) K933256

FAN BEAM COLLIMATOR by Siemens Gammasonics, Inc. — Product Code IYX

K933256 is an FDA 510(k) premarket notification submitted by Siemens Gammasonics, Inc. for the device "FAN BEAM COLLIMATOR". The FDA issued a decision of Substantially Equivalent on October 29, 1993. The device falls under product code IYX (Camera, Scintillation (Gamma)), a Class I device regulated under 21 CFR 892.1100. Siemens Gammasonics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 1993
Date Received
July 6, 1993
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 Siemens Gammasonics, Inc.

  • K934766 — CARBON FIBER PALLET (February 18, 1994)
  • K933664 — POLYTRON T.O.P. (TIME, OPERATION, PERFORMANCE) (December 15, 1993)
  • K920319 — SIENET IMAGE DISPLAY WORKSTATIONS, IMAGE ACQUISITI (October 20, 1992)
  • K923582 — SIENET CAMERA SERVER (October 14, 1992)
  • K922373 — MULTISPECT(TM) 2 DUAL DETECTOR CAMERA SYSTEM (August 17, 1992)
  • K922372 — MULTISPECT(TM) 3 TRIPLE DETECTOR CAMERA SYSTEM (August 17, 1992)
  • K920310 — SIENET ARCHIVE SERVER, ISA I, ISA II STORAGE SERVE (March 30, 1992)
  • K920309 — SIENET DIAGNOSTIC REPORTING CONSOLE (March 20, 1992)
  • K914313 — HICOR (November 27, 1991)
  • K914350 — ICON COMPUTER SYSTEM (November 22, 1991)

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