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510(k) K912180

MODEL MGB-301 DIAPHRAGM FILM 24 X 30 CM by Instrumentarium Imaging, Inc. — Product Code IZX

K912180 is an FDA 510(k) premarket notification submitted by Instrumentarium Imaging, Inc. for the device "MODEL MGB-301 DIAPHRAGM FILM 24 X 30 CM". The FDA issued a decision of Substantially Equivalent on October 21, 1991. The device falls under product code IZX (Collimator, Manual, Radiographic), a Class II device regulated under 21 CFR 892.1610. Instrumentarium Imaging, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 1991
Date Received
May 16, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Collimator, Manual, Radiographic
Device Class
Class II
Regulation Number
892.1610
Review Panel
RA
Submission Type

Other clearances by Instrumentarium Imaging, Inc.

  • K002472 — DELTA 32 AND DELTA 32 TACT (November 29, 2000)
  • K001928 — SIGMA (August 2, 2000)
  • K000976 — DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM) (June 1, 2000)
  • K001171 — DELTA 16 TACT (May 12, 2000)
  • K973642 — ORTHOPANTOMOGRAPH OP100 AND ORTHOCEPH OC100 (November 21, 1997)
  • K955411 — DELTA 16 (March 21, 1996)
  • K925987 — INSTRUMENTARIUM MEGA4 HT (May 19, 1993)
  • K924921 — INSTRUMENTARIUM MEGA4 HT (May 17, 1993)
  • K924472 — INSTRUMENTARIUM MEGA4 HT (May 3, 1993)
  • K923581 — INSTRUMENTARIUM MEGA4 HT (May 3, 1993)

Other clearances for product code IZX

  • K110856 — RALCO (August 10, 2011)
  • K101036 — SHIMADZU COLLIMATOR R-20J (August 26, 2010)
  • K042840 — SHIMADZU COLLIMATOR R-20J (December 3, 2004)
  • K031771 — SHIMADZU COLLIMATOR R-30H (August 21, 2003)
  • K981267 — FACTS MONOBLOCK (May 6, 1998)
  • K974240 — LIGHTLINE-M (December 22, 1997)
  • K972966 — AXT 150M MANUAL COLLIMATOR (AXT 150M) (August 21, 1997)
  • K932134 — RINN UNIVERSAL COLLIMATOR (July 26, 1993)
  • K900007 — R-100-ET MANUAL COLLIMATOR (February 6, 1990)
  • K896486 — R-150-ET COLLIMATOR (January 23, 1990)

FDA data resources