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510(k) K000159

AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO by Agfa Corp. — Product Code IXK

K000159 is an FDA 510(k) premarket notification submitted by Agfa Corp. for the device "AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO". The FDA issued a decision of Substantially Equivalent on February 16, 2000. The device falls under product code IXK (System, Imaging, X-Ray, Electrostatic), a Class II device regulated under 21 CFR 892.1630. Agfa Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 2000
Date Received
January 19, 2000
Clearance Type
Special
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 Agfa Corp.

  • K063421 — DX-SI (November 22, 2006)
  • K053458 — WEB1000 (December 22, 2005)
  • K050751 — IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X (April 21, 2005)
  • K050810 — AGFA CR50.0 (April 21, 2005)
  • K042779 — RADIOTHERAPY SOLUTION BASED ON CR (October 21, 2004)
  • K041701 — AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM (July 22, 2004)
  • K040555 — IMPAX CLIENT EMBRACE (May 26, 2004)
  • K040344 — IMPAX OT3000 ORTHOPEDIC WORKSTATION (May 12, 2004)
  • K032635 — DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 5300 (September 24, 2003)
  • K023287 — DRYSTAR 5500 (October 22, 2002)

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)
  • 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)
  • K923990 — FUJI COMPUTED RADIOGRAPHY HI-C652B DMS CRT IMAGE (December 17, 1992)

FDA data resources