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510(k) K932356

NOVA XM2 by Dynarad Corp. — Product Code IZH

K932356 is an FDA 510(k) premarket notification submitted by Dynarad Corp. for the device "NOVA XM2". The FDA issued a decision of Substantially Equivalent on February 8, 1995. The device falls under product code IZH (System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1710. Dynarad Corp. has at least 8 other 510(k) clearances on record.

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.

  • K000052 — X-RAY MONOBLOCK, MONOBLOCK XRS-60-330 (February 10, 2000)
  • K981267 — FACTS MONOBLOCK (May 6, 1998)
  • 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)

Other clearances for product code IZH

  • K203509 — SMART FINDER (July 14, 2021)
  • K202294 — Affirm Contrast Biopsy (October 5, 2020)
  • K191495 — Biopsy Positioner (July 3, 2019)
  • K161575 — Affirm Lateral Arm Upright Biopsy Accessory (August 10, 2016)
  • K161920 — Comfort Cover (July 15, 2016)
  • K153486 — Affirm Prone Biopsy System (April 1, 2016)
  • K152038 — MammoGRIP (December 22, 2015)
  • K123414 — SPECBOARD JR. (January 11, 2013)
  • K122836 — AFFIRM BREAST BIOPSY GUIDANCE SYSTEM (January 11, 2013)
  • K113607 — BIOPSY DIGIT S BIOPSY SL (August 10, 2012)

FDA data resources