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510(k) K093596

LUMOS, MODEL R 72B by Lumos, Inc. — Product Code KPW

K093596 is an FDA 510(k) premarket notification submitted by Lumos, Inc. for the device "LUMOS, MODEL R 72B". The FDA issued a decision of Substantially Equivalent on January 12, 2010. 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
January 12, 2010
Date Received
November 20, 2009
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

  • K062788 — COLLIMATOR, MODEL M-38 (December 28, 2006)
  • 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