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510(k) K946262

EURO, SCST, SCCFT ATLAS RADIOLOGIC TABLES by Scott Imaging Intl., Inc. — Product Code IXQ

K946262 is an FDA 510(k) premarket notification submitted by Scott Imaging Intl., Inc. for the device "EURO, SCST, SCCFT ATLAS RADIOLOGIC TABLES". The FDA issued a decision of Substantially Equivalent on February 15, 1995. The device falls under product code IXQ (Table, Radiographic, Stationary Top), a Class II device regulated under 21 CFR 892.1980. 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
Table, Radiographic, Stationary Top
Device Class
Class II
Regulation Number
892.1980
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)
  • K946261 — MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5000 (February 15, 1995)
  • K945709 — SII 525 MS (December 14, 1994)
  • K945708 — SII 360 MS (December 14, 1994)

Other clearances for product code IXQ

  • K973842 — CARBON FIBER CONFORMAL COUCH TOP (December 5, 1997)
  • K960083 — MOVABLE CANTILEVERED RADIOGRAPHIC TABLE XRT 100, 200 & 300 (July 24, 1996)
  • K954225 — MED-TEC HAND GRIP (November 14, 1995)
  • K942916 — OCTOPAQUE UNIVERSAL (September 8, 1994)
  • K942190 — ID100 MOBILE FLUOROSCOPIC EXAMINING TABLE (August 17, 1994)
  • K913425 — DIAL-A-RAD PORTA RAD TABLE (November 24, 1992)
  • K923775 — R-MADE HEAD/ARM SUPPORT (October 20, 1992)
  • K920729 — BUCKY TABLE BK-12 (April 27, 1992)
  • K914351 — CLINITRON C-10 (February 14, 1992)
  • K912382 — MILITARY RADIOGRAPHIC FLAT TABLE, CAT # T-9130 (October 10, 1991)

FDA data resources