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510(k) K883864

RADKOR SFR-70 by Radkor, Inc. — Product Code IYB

K883864 is an FDA 510(k) premarket notification submitted by Radkor, Inc. for the device "RADKOR SFR-70". The FDA issued a decision of Substantially Equivalent on October 19, 1988. The device falls under product code IYB (Tube Mount, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1770. Radkor, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 1988
Date Received
September 13, 1988
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 Radkor, Inc.

  • K895969 — RADKOR DXG-650R (November 13, 1989)
  • K892196 — RADKOR TS10-B (April 26, 1989)
  • K891395 — RADKOR BS-10 AND BS-10T (April 3, 1989)
  • K883885 — RADKOR, RF-159 (October 19, 1988)
  • K881701 — RADKOR SFC-21 (September 8, 1988)
  • K881700 — RADKOR KOB-84 (September 2, 1988)
  • K881696 — RADKOR XG-325 (September 2, 1988)
  • K883081 — RADKOR, XG-515 (September 2, 1988)
  • K882563 — RADKOR, CST-18 (July 8, 1988)

Other clearances for product code IYB

  • K935123 — SUPERSTAND 300 (March 27, 1996)
  • K946261 — MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5000 (February 15, 1995)
  • K941017 — F/C/W TUBESTAND (July 29, 1994)
  • K941004 — CTS SYSTEM (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)

FDA data resources