Home / 510(k) Clearances / K853459

510(k) K853459

XERORADIOGRAPHY LIQUID TONER IMAGING SYSTEM by Xerox Medical Systems — Product Code IXK

K853459 is an FDA 510(k) premarket notification submitted by Xerox Medical Systems for the device "XERORADIOGRAPHY LIQUID TONER IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on October 30, 1985. The device falls under product code IXK (System, Imaging, X-Ray, Electrostatic), a Class II device regulated under 21 CFR 892.1630. Xerox Medical Systems has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1985
Date Received
August 16, 1985
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

Other clearances by Xerox Medical Systems

  • K833243 — MAMMOGRAPHIC S-RAY SYSTEM (October 28, 1983)
  • K832733 — XEROX 120 SYS MAMMOGRAPHIC X-RAY (September 29, 1983)
  • K812024 — XEROX 128 CASSETTE CHANGER (August 13, 1981)
  • K791014 — DENTAL XERORADIOGRAPHY (September 4, 1979)

Other clearances for product code IXK

  • K093640 — DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA (April 29, 2011)
  • K072766 — PVMED DDR 2520 DIGITAL IMAGING SYSTEM (December 11, 2007)
  • K042779 — RADIOTHERAPY SOLUTION BASED ON CR (October 21, 2004)
  • K032654 — PORT CASSETTE (October 9, 2003)
  • K003689 — CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31 (January 2, 2002)
  • K000159 — AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO (February 16, 2000)
  • K942561 — FUJI FCR IMAGE PROCESSING UNIT IP-U515 (December 23, 1994)
  • K934949 — DIGORA (February 10, 1994)
  • K931002 — FUJI COMPUTED RADIOGRAP HI-C654 DMS CRT IMAGE CONS (June 8, 1993)
  • K924459 — DIGISCAN 2 (December 17, 1992)

FDA data resources