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510(k) K042779

RADIOTHERAPY SOLUTION BASED ON CR by Agfa Corp. — Product Code IXK

K042779 is an FDA 510(k) premarket notification submitted by Agfa Corp. for the device "RADIOTHERAPY SOLUTION BASED ON CR". The FDA issued a decision of Substantially Equivalent on October 21, 2004. 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
October 21, 2004
Date Received
October 6, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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)
  • K050810 — AGFA CR50.0 (April 21, 2005)
  • K050751 — IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X (April 21, 2005)
  • 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)
  • K023020 — AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX (September 26, 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)
  • 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)
  • K923990 — FUJI COMPUTED RADIOGRAPHY HI-C652B DMS CRT IMAGE (December 17, 1992)
  • K924459 — DIGISCAN 2 (December 17, 1992)

FDA data resources