Home / 510(k) Clearances / K913301

510(k) K913301

MCS 50MO X-RAY TUBE INSERT/MXS 50MO TUBE HOU ASSEM by Comet North America, Inc. — Product Code ITY

K913301 is an FDA 510(k) premarket notification submitted by Comet North America, Inc. for the device "MCS 50MO X-RAY TUBE INSERT/MXS 50MO TUBE HOU ASSEM". The FDA issued a decision of Substantially Equivalent on August 28, 1991. The device falls under product code ITY (Assembly, Tube Housing, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1760.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 1991
Date Received
July 25, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assembly, Tube Housing, X-Ray, Diagnostic
Device Class
Class I
Regulation Number
892.1760
Review Panel
RA
Submission Type

Other clearances for product code ITY

  • K000052 — X-RAY MONOBLOCK, MONOBLOCK XRS-60-330 (February 10, 2000)
  • K933162 — MRX-750 (October 7, 1993)
  • K923094 — MOLYBDENUM (March 4, 1993)
  • K923141 — PHILIPS PRE-FILTER OPTION (January 21, 1993)
  • K921129 — MRX-700 (October 5, 1992)
  • K921130 — MRX-865 (September 10, 1992)
  • K921316 — MG-1001 TUBE HOUSING ASSEMBLY (June 22, 1992)
  • K920731 — X-RAY TUBE ASSEMBLY CIRCLEX1.2UG (May 29, 1992)
  • K920723 — HIGH SPEED ROTATION STARTER SA-40 (April 27, 1992)
  • K920724 — HIGH SPEED ROTATION STARTER SA-50 (April 27, 1992)

FDA data resources