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510(k) K761022

XERORADIOGRAPHY 125 SYSTEM - MODIFIED by Xeroradiography — Product Code IXK

K761022 is an FDA 510(k) premarket notification submitted by Xeroradiography for the device "XERORADIOGRAPHY 125 SYSTEM - MODIFIED". The FDA issued a decision of Substantially Equivalent on November 24, 1976. The device falls under product code IXK (System, Imaging, X-Ray, Electrostatic), a Class II device regulated under 21 CFR 892.1630.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1976
Date Received
November 11, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, X-Ray, Electrostatic
Device Class
Class II
Regulation Number
892.1630
Review Panel
RA
Submission Type

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  • K931002 — FUJI COMPUTED RADIOGRAP HI-C654 DMS CRT IMAGE CONS (June 8, 1993)
  • K924459 — DIGISCAN 2 (December 17, 1992)

FDA data resources