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510(k) K820119

PODIOSCOPE BY ARROW by Arrow X-Ray Corp. — Product Code KPW

K820119 is an FDA 510(k) premarket notification submitted by Arrow X-Ray Corp. for the device "PODIOSCOPE BY ARROW". The FDA issued a decision of Substantially Equivalent on February 18, 1982. The device falls under product code KPW (Device, Beam Limiting, X-Ray, Diagnostic), a Class II device regulated under 21 CFR 892.1610. Arrow X-Ray Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 1982
Date Received
January 18, 1982
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 by Arrow X-Ray Corp.

  • K827069 — PODIOSCOPE BY ARROW (February 18, 1982)

Other clearances for product code KPW

  • K093596 — LUMOS, MODEL R 72B (January 12, 2010)
  • 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)

FDA data resources