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510(k) K990969

KONICA SRX- 701 AUTOMATIC X-RAY FILM PROCESSOR by Konica Medical Corp. — Product Code IXW

K990969 is an FDA 510(k) premarket notification submitted by Konica Medical Corp. for the device "KONICA SRX- 701 AUTOMATIC X-RAY FILM PROCESSOR". The FDA issued a decision of Substantially Equivalent on June 18, 1999. The device falls under product code IXW (Processor, Radiographic-Film, Automatic), a Class II device regulated under 21 CFR 892.1900. Konica Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 1999
Date Received
March 23, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Processor, Radiographic-Film, Automatic
Device Class
Class II
Regulation Number
892.1900
Review Panel
RA
Submission Type

Other clearances by Konica Medical Corp.

  • K963914 — CM & CM DS-7 (October 8, 1997)
  • 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 IXW

  • K111167 — XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT (August 18, 2011)
  • K093503 — INTRAX FILM PROCESSOR (January 6, 2010)
  • K091628 — OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX (August 21, 2009)
  • K024342 — RADIOGRAPHIC FILM PROCESSOR, MODELS XP400 AND XP1000 (April 23, 2003)
  • K023825 — FILM PROCESSOR, MODEL LIFE RAY PRO 2500 (February 12, 2003)
  • K023801 — FILM PROCESSOR, MODEL LIFE RAY PRO 1000 (February 12, 2003)
  • K023613 — AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036 (January 23, 2003)
  • K022154 — LEVEL 356 X-RAY FILM PROCESSOR, MODELS MD & MD-D (September 30, 2002)
  • K002640 — FREEDOM AUTOMATIC FILM PROCESSOR (November 8, 2000)
  • K002404 — MICRO-MAX, MODEL 319 (August 30, 2000)

FDA data resources