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510(k) K902146

SFD-035 SPOT FILM DEVICE by Rms Div. — Product Code IXL

K902146 is an FDA 510(k) premarket notification submitted by Rms Div. for the device "SFD-035 SPOT FILM DEVICE". The FDA issued a decision of Substantially Equivalent on May 31, 1990. The device falls under product code IXL (Device, Spot-Film), a Class II device regulated under 21 CFR 892.1670. Rms Div. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 1990
Date Received
May 14, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Spot-Film
Device Class
Class II
Regulation Number
892.1670
Review Panel
RA
Submission Type

Other clearances by Rms Div.

  • K963367 — RMS K-WIRE (October 30, 1996)
  • K954438 — SUNMED'S GREENLINE FIBER OPTIC LARYNGOSCOPE (December 29, 1995)
  • K944848 — THE VIVACARE T.P.S. PROBE (December 14, 1994)
  • K944557 — DW250 #91 (November 3, 1994)
  • K941625 — DW234 #29 (June 22, 1994)
  • K902403 — ELITE R/F SPOT FILM DRIVE (August 1, 1990)
  • K896665 — EXT-600 TABLE, RADIOGRAPHIC, ELEVATING (January 22, 1990)
  • K896119 — RMS 90/15 RADIOGRAPHIC/FLUOROSCOPIC TILTING TABLE (November 27, 1989)
  • K896324 — ELITE 1500 RADIOGRAPHIC TILTING TABLE (November 21, 1989)

Other clearances for product code IXL

  • K111304 — OPTIMA XR120 (July 19, 2011)
  • K964806 — MD-1835 (March 4, 1997)
  • K950317 — ADVANTX 1824 SPOTFILM DEVICE (February 8, 1995)
  • K940386 — KODAK AUTOMIXER III INTEGRATED, KODAK AUTOMIXER III 180 LP (August 17, 1994)
  • K942367 — AXT 1400 SPOTFILM DEVICE (June 6, 1994)
  • K924593 — DIAGNOST 76 FAMILY*R/F SYSTEMS - RELEASE 4.4 (November 24, 1992)
  • K902403 — ELITE R/F SPOT FILM DRIVE (August 1, 1990)
  • K882492 — A.X.T. SPOTFILM DEVICE (July 21, 1988)
  • K881589 — 14X14 MULTIFORMAT SPOT FILMER, NO. 6650.400 (July 18, 1988)
  • K842184 — SPOT-FILM DEVICE 8835 (July 17, 1984)

FDA data resources