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510(k) K053173

DS CASSETTE by Konica Minolta Medical & Graphic, Inc. — Product Code IXA

K053173 is an FDA 510(k) premarket notification submitted by Konica Minolta Medical & Graphic, Inc. for the device "DS CASSETTE". The FDA issued a decision of Substantially Equivalent on December 15, 2005. The device falls under product code IXA (Cassette, Radiographic Film), a Class II device regulated under 21 CFR 892.1850. Konica Minolta Medical & Graphic, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2005
Date Received
November 14, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cassette, Radiographic Film
Device Class
Class II
Regulation Number
892.1850
Review Panel
RA
Submission Type

Other clearances by Konica Minolta Medical & Graphic, Inc.

  • K130936 — AERODR SYSTEM WITH P-31 (August 22, 2013)
  • K123499 — AEROPILOT (December 20, 2012)
  • K120752 — AERODR STITCHING SYSTEM (June 8, 2012)
  • K121109 — AERODR X70 (May 23, 2012)
  • K120477 — AEROSYNC FOR AERODR SYSTEM (April 9, 2012)
  • K120131 — REGIUS SIGMA2 (February 10, 2012)
  • K113248 — AERODR SYSTEM WITH P-21 (January 17, 2012)
  • K110717 — KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM (December 23, 2011)
  • K103703 — REGUIS SIGMA (June 2, 2011)
  • K101842 — ACIES (February 4, 2011)

Other clearances for product code IXA

  • K081557 — PORTABLE SUPINE PATIENT SUPPORT AND CASSETTE HOLDER (September 10, 2008)
  • K040378 — KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253 (May 24, 2004)
  • K023020 — AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX (September 26, 2002)
  • K021903 — KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE (July 10, 2002)
  • K013686 — KODAK DIRECTVIEW TABLETOP CASSETTE (December 7, 2001)
  • K013229 — LIFERAY FW MAMMO CASSETTE, LIFERAY KW MAMMO CASETTE (October 12, 2001)
  • K012373 — LIFERAY WL CASSETTE, LIFERAY KW CASSETTE (August 9, 2001)
  • K983918 — RADIOLUCENT CASSETTE LIMB POSITIONER (R-CLIP) (March 12, 1999)
  • K980722 — TRIMAX RADIOGRAPHIC CASSETTE (March 23, 1998)
  • K963914 — CM & CM DS-7 (October 8, 1997)

FDA data resources