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510(k) K946261

MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5000 by Scott Imaging Intl., Inc. — Product Code IYB

K946261 is an FDA 510(k) premarket notification submitted by Scott Imaging Intl., Inc. for the device "MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5000". The FDA issued a decision of Substantially Equivalent on February 15, 1995. The device falls under product code IYB (Tube Mount, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1770. Scott Imaging Intl., Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 1995
Date Received
December 13, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube Mount, X-Ray, Diagnostic
Device Class
Class I
Regulation Number
892.1770
Review Panel
RA
Submission Type

Other clearances by Scott Imaging Intl., Inc.

  • K946260 — NTBS-1417, 1436, TBS-1417 (March 31, 1995)
  • K950040 — SII 525 APR (March 21, 1995)
  • K950041 — SII 360 APR (March 21, 1995)
  • K946262 — EURO, SCST, SCCFT ATLAS RADIOLOGIC TABLES (February 15, 1995)
  • K945709 — SII 525 MS (December 14, 1994)
  • K945708 — SII 360 MS (December 14, 1994)

Other clearances for product code IYB

  • K935123 — SUPERSTAND 300 (March 27, 1996)
  • K941004 — CTS SYSTEM (July 29, 1994)
  • K941017 — F/C/W TUBESTAND (July 29, 1994)
  • K940442 — MPR-814 (June 9, 1994)
  • K935004 — MODEL ALPHA TS-2 (December 13, 1993)
  • K933253 — SUPERSTAND 3000 (August 16, 1993)
  • K925716 — BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC (December 17, 1992)
  • K925170 — SHIMADZU X-RAY TUBE STAND BH-100 SERIES (December 7, 1992)
  • K920727 — CEILING TUBE SUPPORT CH-30X (April 16, 1992)
  • K914944 — BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC (December 2, 1991)

FDA data resources