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510(k) K974240

LIGHTLINE-M by Wuestec Medical, Inc. — Product Code IZX

K974240 is an FDA 510(k) premarket notification submitted by Wuestec Medical, Inc. for the device "LIGHTLINE-M". The FDA issued a decision of Substantially Equivalent on December 22, 1997. The device falls under product code IZX (Collimator, Manual, Radiographic), a Class II device regulated under 21 CFR 892.1610. Wuestec Medical, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1997
Date Received
November 12, 1997
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 Wuestec Medical, Inc.

  • K993962 — PENSIL TRAUMA, MODEL WWS6100 (December 21, 1999)
  • K992603 — XRT 600 R/F, WRF 0600 (October 25, 1999)
  • K992103 — C-QUEST (September 1, 1999)
  • K981880 — DX-480, ADD ON DIGITAL IMAGER (October 20, 1998)
  • K955414 — XRT 400 (July 24, 1996)
  • K960083 — MOVABLE CANTILEVERED RADIOGRAPHIC TABLE XRT 100, 200 & 300 (July 24, 1996)
  • K935123 — SUPERSTAND 300 (March 27, 1996)
  • K933253 — SUPERSTAND 3000 (August 16, 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)
  • 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