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510(k) K941363

PHANTOM by Dynarad Corp. — Product Code IZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1994
Date Received
March 21, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mobile
Device Class
Class II
Regulation Number
892.1720
Review Panel
RA
Submission Type

Other clearances by Dynarad Corp.

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  • K932356 — NOVA XM2 (February 8, 1995)
  • 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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