Home / 510(k) Clearances / K910308

510(k) K910308

X-RAY TUBE HOUSING ASSEMBLY POLARIX II GEN/XO 110 by Inmark Corp. — Product Code ITY

K910308 is an FDA 510(k) premarket notification submitted by Inmark Corp. for the device "X-RAY TUBE HOUSING ASSEMBLY POLARIX II GEN/XO 110". The FDA issued a decision of Substantially Equivalent on March 27, 1991. The device falls under product code ITY (Assembly, Tube Housing, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1760. Inmark Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 1991
Date Received
January 24, 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 Inmark Corp.

  • K910276 — X-RAY TUBE HOUSING ASSEMBLY SOREDEX DC/CIR 51 (March 6, 1991)
  • K894742 — RELOADING OF X-RAY TUBE HOUSING ASSEM., VARIOUS (October 27, 1989)
  • K894413 — X-RAY TUBE HOUSING ASSEMBLY, VARIOUS MODELS (September 22, 1989)

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