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510(k) K915667

MODEL H170 PEDIATRIC CHEST X-RAY UNIT by H.L. Lyons Co. — Product Code IXY

K915667 is an FDA 510(k) premarket notification submitted by H.L. Lyons Co. for the device "MODEL H170 PEDIATRIC CHEST X-RAY UNIT". The FDA issued a decision of Substantially Equivalent on January 31, 1992. The device falls under product code IXY (Holder, Radiographic Cassette, Wall-Mounted), a Class I device regulated under 21 CFR 892.1880.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 1992
Date Received
December 18, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holder, Radiographic Cassette, Wall-Mounted
Device Class
Class I
Regulation Number
892.1880
Review Panel
RA
Submission Type

Other clearances for product code IXY

  • K953402 — UNIVERSIX 190 (August 11, 1995)
  • K953336 — VRS 3 WALL STAND (August 11, 1995)
  • K946114 — SENSORI-MOTOR RATING SCALE (April 28, 1995)
  • K946260 — NTBS-1417, 1436, TBS-1417 (March 31, 1995)
  • K930230 — RADIOGRAPHIC WALL-MOUNTED CASSETTE HOLDER (April 27, 1993)
  • K930249 — BC/WT/PF (April 27, 1993)
  • K925934 — WALL BUCKY HOLDERS LT. & RT. HAND, & CENTER MOUNT (March 4, 1993)
  • K924445 — BA-4 WALL BUCKY AND BA-42 TILTING WALL BUCKY (February 19, 1993)
  • K922443 — VERT-X UNIVERSAL VERTICAL BUCKY STAND (October 26, 1992)
  • K895034 — BUCKYS MODELS YMB-15A, YMB-15B AND YMB-15C (November 15, 1989)

FDA data resources