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510(k) K904182

R-800-SF by Advantech — Product Code ITY

K904182 is an FDA 510(k) premarket notification submitted by Advantech for the device "R-800-SF". The FDA issued a decision of Substantially Equivalent on November 13, 1990. The device falls under product code ITY (Assembly, Tube Housing, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1760. Advantech has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 1990
Date Received
September 11, 1990
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 by Advantech

  • K900007 — R-100-ET MANUAL COLLIMATOR (February 6, 1990)
  • K896486 — R-150-ET COLLIMATOR (January 23, 1990)

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