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510(k) K981267

FACTS MONOBLOCK by Dynarad Corp. — Product Code IZX

K981267 is an FDA 510(k) premarket notification submitted by Dynarad Corp. for the device "FACTS MONOBLOCK". The FDA issued a decision of Substantially Equivalent on May 6, 1998. The device falls under product code IZX (Collimator, Manual, Radiographic), a Class II device regulated under 21 CFR 892.1610. Dynarad Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 1998
Date Received
April 7, 1998
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 Dynarad Corp.

  • K000052 — X-RAY MONOBLOCK, MONOBLOCK XRS-60-330 (February 10, 2000)
  • K973833 — CONTROL, X-RAY DIAGNOSTIC, GENERATOR, HIGH VOLTAGE, ASSEMBLY, TUBE HOUSING DIAGN (December 30, 1997)
  • K932356 — NOVA XM2 (February 8, 1995)
  • K941363 — PHANTOM (July 20, 1994)
  • K932353 — HF-110A (January 31, 1994)
  • K932355 — 9150A, 1100F (August 3, 1993)
  • K932354 — 9170, 1170 (July 23, 1993)
  • K931725 — ALPHA II (July 14, 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)
  • K974240 — LIGHTLINE-M (December 22, 1997)
  • K972966 — AXT 150M MANUAL COLLIMATOR (AXT 150M) (August 21, 1997)
  • K932134 — RINN UNIVERSAL COLLIMATOR (July 26, 1993)
  • 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