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510(k) K032635

DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 5300 by Agfa Corp. — Product Code LMC

K032635 is an FDA 510(k) premarket notification submitted by Agfa Corp. for the device "DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 5300". The FDA issued a decision of Substantially Equivalent on September 24, 2003. The device falls under product code LMC (Camera, Multi Format, Radiological), a Class II device regulated under 21 CFR 892.2040. Agfa Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 2003
Date Received
August 26, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Multi Format, Radiological
Device Class
Class II
Regulation Number
892.2040
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)
  • 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)
  • 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 LMC

  • K141454 — SONY DIGITAL PRINTER UP-D898MD/SONY HYBRID PRINTER UP-X898MD (June 26, 2014)
  • K141346 — SONY HYBIRD GRAPHIC UP-971AD, SONY HYBIRD GRAPHIC PRINTER UP-991AD (June 26, 2014)
  • K111566 — DRYVIEW CHROMA IMAGING SYSTEM (October 6, 2011)
  • K092280 — CYPHER DICOM PRINT SOLUTION (October 16, 2009)
  • K090469 — CARESTREAM DRYVIEW 5850 LASER IMAGER (May 22, 2009)
  • K083522 — SONY UP-DF750 DIGITAL FILM IMAGER (January 9, 2009)
  • K081637 — LASER IMAGER DRYPRO MODEL 873 (July 1, 2008)
  • K072680 — DRYSTAR AXYS, MODEL EYZ4E (October 25, 2007)
  • K061999 — DRY LASER IMAGER, DRYPRO MODEL 832 (August 15, 2006)
  • K061302 — DIGITAL PRINTER P6000D SERIES, MODEL P6000DU (June 23, 2006)

FDA data resources