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510(k) K951315

CATHETERIZATION TABLE KS-60 by Shimadzu Medical Systems — Product Code IZZ

K951315 is an FDA 510(k) premarket notification submitted by Shimadzu Medical Systems for the device "CATHETERIZATION TABLE KS-60". The FDA issued a decision of Substantially Equivalent on May 11, 1995. The device falls under product code IZZ (Table, Radiographic, Non-Tilting, Powered), a Class II device regulated under 21 CFR 892.1980. Shimadzu Medical Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 1995
Date Received
March 23, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Radiographic, Non-Tilting, Powered
Device Class
Class II
Regulation Number
892.1980
Review Panel
RA
Submission Type

Other clearances by Shimadzu Medical Systems

  • K082224 — DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC (December 15, 2008)
  • K071291 — ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100 (January 9, 2008)
  • K071287 — ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND DEVICE, MODEL SDU-2200PRO (January 9, 2008)
  • K071289 — ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO (January 9, 2008)
  • K061643 — ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO (July 27, 2006)
  • K061637 — ECHOVIEW/ SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200PRO (July 25, 2006)
  • K061641 — ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SARANO (July 14, 2006)
  • K052500 — DAR-8000F (October 17, 2005)
  • K052076 — DAR-8000I (September 2, 2005)
  • K050510 — ECHOVIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100 (April 1, 2005)

Other clearances for product code IZZ

  • K971452 — MULTIX TOP/PRO RADIOGRAPHIC X-RAY TABLE (May 14, 1997)
  • K952701 — MED-TRON SPECT IMAGING TABLE (July 6, 1995)
  • K951053 — ANGIOREX CAT-350B (April 6, 1995)
  • K943926 — RAPIDO 2000 AUTOMATIC RADIOGRAPHIC TABLE (November 28, 1994)
  • K930273 — ALPHA (July 13, 1993)
  • K924444 — B-4 FOUR-WAY RADIOGRAPHIC TABLE (February 5, 1993)
  • K925174 — SHIMADZU RADIOGRAPHIC TABLE BK-100 (November 27, 1992)
  • K921501 — DELUXE C ARM RADIOLOGICAL TABLE, MODEL #056-004 (May 15, 1992)
  • K920732 — CATHERIZATION KS-50 (April 16, 1992)
  • K915413 — CAT-250B (December 19, 1991)

FDA data resources