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510(k) K881701

RADKOR SFC-21 by Radkor, Inc. — Product Code IYB

K881701 is an FDA 510(k) premarket notification submitted by Radkor, Inc. for the device "RADKOR SFC-21". The FDA issued a decision of Substantially Equivalent on September 8, 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
September 8, 1988
Date Received
April 19, 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)
  • K883864 — RADKOR SFR-70 (October 19, 1988)
  • K883885 — RADKOR, RF-159 (October 19, 1988)
  • K881696 — RADKOR XG-325 (September 2, 1988)
  • K883081 — RADKOR, XG-515 (September 2, 1988)
  • K881700 — RADKOR KOB-84 (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)
  • 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)

FDA data resources