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510(k) K913425

DIAL-A-RAD PORTA RAD TABLE by Dial-A-Rad — Product Code IXQ

K913425 is an FDA 510(k) premarket notification submitted by Dial-A-Rad for the device "DIAL-A-RAD PORTA RAD TABLE". The FDA issued a decision of Substantially Equivalent on November 24, 1992. The device falls under product code IXQ (Table, Radiographic, Stationary Top), a Class II device regulated under 21 CFR 892.1980.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1992
Date Received
August 1, 1991
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 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)
  • K946262 — EURO, SCST, SCCFT ATLAS RADIOLOGIC TABLES (February 15, 1995)
  • K942916 — OCTOPAQUE UNIVERSAL (September 8, 1994)
  • K942190 — ID100 MOBILE FLUOROSCOPIC EXAMINING TABLE (August 17, 1994)
  • 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