Home / 510(k) Clearances / K973833

510(k) K973833

CONTROL, X-RAY DIAGNOSTIC, GENERATOR, HIGH VOLTAGE, ASSEMBLY, TUBE HOUSING DIAGNOSTIC, BEAM LIMITING DEVICE, MANUAL by Dynarad Corp. — Product Code IZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1997
Date Received
October 7, 1997
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

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  • K932354 — 9170, 1170 (July 23, 1993)
  • K931725 — ALPHA II (July 14, 1993)

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