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510(k) K910842

DI2000/HS-45-150 X-RAY TUBE INSERT by Comet Ltd. C/O Radiology Resources, Inc. — Product Code ITY

K910842 is an FDA 510(k) premarket notification submitted by Comet Ltd. C/O Radiology Resources, Inc. for the device "DI2000/HS-45-150 X-RAY TUBE INSERT". The FDA issued a decision of Substantially Equivalent on March 6, 1991. The device falls under product code ITY (Assembly, Tube Housing, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1760. Comet Ltd. C/O Radiology Resources, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1991
Date Received
February 27, 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 by Comet Ltd. C/O Radiology Resources, Inc.

  • K912338 — TUBE HOUSING ASSEMBLIES (August 7, 1991)
  • K911695 — VARIOUS X-RAY TUBES (June 19, 1991)
  • K901997 — X-RAY TUBE HOUSING ASSEMBLY, VARIOUS MODELS (June 6, 1990)
  • K864749 — TELAMAT (February 10, 1987)

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