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510(k) K932356

NOVA XM2 by Dynarad Corp. — Product Code IZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 1995
Date Received
May 13, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mammographic
Device Class
Class II
Regulation Number
892.1710
Review Panel
RA
Submission Type

Other clearances by Dynarad Corp.

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  • K973833 — CONTROL, X-RAY DIAGNOSTIC, GENERATOR, HIGH VOLTAGE, ASSEMBLY, TUBE HOUSING DIAGN (December 30, 1997)
  • 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)

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