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510(k) K963914

CM & CM DS-7 by Konica Medical Corp. — Product Code IXA

K963914 is an FDA 510(k) premarket notification submitted by Konica Medical Corp. for the device "CM & CM DS-7". The FDA issued a decision of Substantially Equivalent on October 8, 1997. The device falls under product code IXA (Cassette, Radiographic Film), a Class II device regulated under 21 CFR 892.1850. Konica Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 1997
Date Received
September 30, 1996
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 Medical Corp.

  • K990969 — KONICA SRX- 701 AUTOMATIC X-RAY FILM PROCESSOR (June 18, 1999)
  • K963913 — MD100 & MM150 (October 8, 1997)
  • K955583 — VIFS (May 14, 1996)
  • K931317 — KONICA SRX-301 AUTOMATIC X-RAY FILM PROCESSOR (December 14, 1993)
  • K933830 — KONICA LD-4500 LASER DIGITIZER (December 14, 1993)
  • K931315 — KONICA SRX-501A AUTOMATIC X-RAY FILM PROCESSOR (December 14, 1993)
  • K931316 — KONICA DS-7 AUTOMATIC X-RAY FILM PROCESSOR (December 14, 1993)
  • K931314 — KONICA QX-70 AUTOMATIC X-RAY FILM PROCESSOR (September 7, 1993)
  • K931313 — KONICA QX-130APLUS AUTOMATIC X-RAY FILM PROCESSOR (September 7, 1993)
  • K931312 — KONICA SRX-101 AUTOMATIC X-RAY FILM PROCESSOR (September 7, 1993)

Other clearances for product code IXA

  • K081557 — PORTABLE SUPINE PATIENT SUPPORT AND CASSETTE HOLDER (September 10, 2008)
  • K053173 — DS CASSETTE (December 15, 2005)
  • 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)

FDA data resources