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510(k) K932134

RINN UNIVERSAL COLLIMATOR by Rinn Corp. — Product Code IZX

K932134 is an FDA 510(k) premarket notification submitted by Rinn Corp. for the device "RINN UNIVERSAL COLLIMATOR". The FDA issued a decision of Substantially Equivalent on July 26, 1993. The device falls under product code IZX (Collimator, Manual, Radiographic), a Class II device regulated under 21 CFR 892.1610. Rinn Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 1993
Date Received
May 3, 1993
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 Rinn Corp.

  • K913885 — RINN E-Z CAPPER (December 13, 1991)
  • K828605 — BEAM LIMITING DEVICE (January 3, 1983)
  • K813378 — UNI-BITE DENTAL X-RAY FILM HOLDER (January 29, 1982)
  • K772313 — X-RAY CO-ORDINATOR (January 30, 1978)

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)
  • K912180 — MODEL MGB-301 DIAPHRAGM FILM 24 X 30 CM (October 21, 1991)
  • K900007 — R-100-ET MANUAL COLLIMATOR (February 6, 1990)
  • K896486 — R-150-ET COLLIMATOR (January 23, 1990)

FDA data resources