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510(k) K953402

UNIVERSIX 190 by Philips Medical Systems (Cleveland), Inc. — Product Code IXY

K953402 is an FDA 510(k) premarket notification submitted by Philips Medical Systems (Cleveland), Inc. for the device "UNIVERSIX 190". The FDA issued a decision of Substantially Equivalent on August 11, 1995. The device falls under product code IXY (Holder, Radiographic Cassette, Wall-Mounted), a Class I device regulated under 21 CFR 892.1880. Philips Medical Systems (Cleveland), Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1995
Date Received
July 20, 1995
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 by Philips Medical Systems (Cleveland), Inc.

  • K171850 — Philips CT Big Bore (November 9, 2017)
  • K172406 — Ingenuity TF (October 6, 2017)
  • K162838 — Philips iCT CT System (April 7, 2017)
  • K163711 — IQon Spectral CT (April 5, 2017)
  • K170086 — Pinnacle Radiation Therapy Planning System (February 9, 2017)
  • K160743 — Philips Ingenuity CT (August 8, 2016)
  • K153444 — Philips Multislice CT System with Low Dose CT Lung Cancer (April 8, 2016)
  • K130992 — PINNACLE3 RADIATION THERAPY PLANNING SYSTEM (June 14, 2013)
  • K111336 — EBW NM 2.0 (May 24, 2011)
  • K111024 — JETPACK 2.0 (April 21, 2011)

Other clearances for product code IXY

  • 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)
  • K915667 — MODEL H170 PEDIATRIC CHEST X-RAY UNIT (January 31, 1992)
  • K895034 — BUCKYS MODELS YMB-15A, YMB-15B AND YMB-15C (November 15, 1989)

FDA data resources