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510(k) K891395

RADKOR BS-10 AND BS-10T by Radkor, Inc. — Product Code IXY

K891395 is an FDA 510(k) premarket notification submitted by Radkor, Inc. for the device "RADKOR BS-10 AND BS-10T". The FDA issued a decision of Substantially Equivalent on April 3, 1989. The device falls under product code IXY (Holder, Radiographic Cassette, Wall-Mounted), a Class I device regulated under 21 CFR 892.1880. Radkor, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 1989
Date Received
March 14, 1989
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 Radkor, Inc.

  • K895969 — RADKOR DXG-650R (November 13, 1989)
  • K892196 — RADKOR TS10-B (April 26, 1989)
  • K883864 — RADKOR SFR-70 (October 19, 1988)
  • 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 IXY

  • K953402 — UNIVERSIX 190 (August 11, 1995)
  • K953336 — VRS 3 WALL STAND (August 11, 1995)
  • K946114 — SENSORI-MOTOR RATING SCALE (April 28, 1995)
  • K946260 — NTBS-1417, 1436, TBS-1417 (March 31, 1995)
  • K930249 — BC/WT/PF (April 27, 1993)
  • K930230 — RADIOGRAPHIC WALL-MOUNTED CASSETTE HOLDER (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)

FDA data resources