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510(k) K062788

COLLIMATOR, MODEL M-38 by Umi International — Product Code KPW

K062788 is an FDA 510(k) premarket notification submitted by Umi International for the device "COLLIMATOR, MODEL M-38". The FDA issued a decision of Substantially Equivalent on December 28, 2006. The device falls under product code KPW (Device, Beam Limiting, X-Ray, Diagnostic), a Class II device regulated under 21 CFR 892.1610.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 2006
Date Received
September 18, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Beam Limiting, X-Ray, Diagnostic
Device Class
Class II
Regulation Number
892.1610
Review Panel
RA
Submission Type

Other clearances for product code KPW

  • K093596 — LUMOS, MODEL R 72B (January 12, 2010)
  • K030487 — R 72 (August 1, 2003)
  • K954310 — BLA-800A (October 18, 1995)
  • K946320 — R 302 (May 11, 1995)
  • K914184 — P2020-8-0 BEAM-LIMITING DEVICE (November 27, 1991)
  • K904587 — DENSICOMP 250 (January 24, 1991)
  • K904044 — TF-63SA (November 29, 1990)
  • K904489 — EUREKA EXTENSION CYLINDERS (October 15, 1990)
  • K820306 — RALCO COLLIMATOR, AUTOMATIC RADIOGRAPHIC (March 5, 1982)
  • K820305 — RALCO COLLIMATORS, MANUAL RADIOGRAPHIC (March 4, 1982)

FDA data resources