Home / 510(k) Clearances / K946260

510(k) K946260

NTBS-1417, 1436, TBS-1417 by Scott Imaging Intl., Inc. — Product Code IXY

K946260 is an FDA 510(k) premarket notification submitted by Scott Imaging Intl., Inc. for the device "NTBS-1417, 1436, TBS-1417". The FDA issued a decision of Substantially Equivalent on March 31, 1995. The device falls under product code IXY (Holder, Radiographic Cassette, Wall-Mounted), a Class I device regulated under 21 CFR 892.1880. Scott Imaging Intl., Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1995
Date Received
December 13, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holder, Radiographic Cassette, Wall-Mounted
Device Class
Class I
Regulation Number
892.1880
Review Panel
RA
Submission Type

Other clearances by Scott Imaging Intl., Inc.

  • K950040 — SII 525 APR (March 21, 1995)
  • K950041 — SII 360 APR (March 21, 1995)
  • K946261 — MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5000 (February 15, 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 IXY

  • K953402 — UNIVERSIX 190 (August 11, 1995)
  • K953336 — VRS 3 WALL STAND (August 11, 1995)
  • K946114 — SENSORI-MOTOR RATING SCALE (April 28, 1995)
  • K930230 — RADIOGRAPHIC WALL-MOUNTED CASSETTE HOLDER (April 27, 1993)
  • K930249 — BC/WT/PF (April 27, 1993)
  • K925934 — WALL BUCKY HOLDERS LT. & RT. HAND, & CENTER MOUNT (March 4, 1993)
  • K924445 — BA-4 WALL BUCKY AND BA-42 TILTING WALL BUCKY (February 19, 1993)
  • K922443 — VERT-X UNIVERSAL VERTICAL BUCKY STAND (October 26, 1992)
  • K915667 — MODEL H170 PEDIATRIC CHEST X-RAY UNIT (January 31, 1992)
  • K895034 — BUCKYS MODELS YMB-15A, YMB-15B AND YMB-15C (November 15, 1989)

FDA data resources