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510(k) K000052

X-RAY MONOBLOCK, MONOBLOCK XRS-60-330 by Dynarad Corp. — Product Code ITY

K000052 is an FDA 510(k) premarket notification submitted by Dynarad Corp. for the device "X-RAY MONOBLOCK, MONOBLOCK XRS-60-330". The FDA issued a decision of Substantially Equivalent on February 10, 2000. The device falls under product code ITY (Assembly, Tube Housing, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1760. Dynarad Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 2000
Date Received
January 7, 2000
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 Dynarad Corp.

  • K981267 — FACTS MONOBLOCK (May 6, 1998)
  • K973833 — CONTROL, X-RAY DIAGNOSTIC, GENERATOR, HIGH VOLTAGE, ASSEMBLY, TUBE HOUSING DIAGN (December 30, 1997)
  • K932356 — NOVA XM2 (February 8, 1995)
  • K941363 — PHANTOM (July 20, 1994)
  • K932353 — HF-110A (January 31, 1994)
  • K932355 — 9150A, 1100F (August 3, 1993)
  • K932354 — 9170, 1170 (July 23, 1993)
  • K931725 — ALPHA II (July 14, 1993)

Other clearances for product code ITY

  • 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)
  • K920387 — CIRCLEXO.3T X-RAY TUBE ASSEMBLY (April 14, 1992)

FDA data resources