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510(k) K873702

REI-38 RADIOGRAPHIC TABLE by Radiological Engineering, Inc. — Product Code IXQ

K873702 is an FDA 510(k) premarket notification submitted by Radiological Engineering, Inc. for the device "REI-38 RADIOGRAPHIC TABLE". The FDA issued a decision of Substantially Equivalent on April 22, 1988. The device falls under product code IXQ (Table, Radiographic, Stationary Top), a Class II device regulated under 21 CFR 892.1980. Radiological Engineering, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 1988
Date Received
September 14, 1987
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 by Radiological Engineering, Inc.

  • K854478 — REI-90/90 RADIOGRAPHIC TABLE (April 17, 1986)
  • K853175 — REI-90/15 (October 10, 1985)
  • K853210 — MST-1050-II X-RAY UNIT (October 10, 1985)

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)
  • K913425 — DIAL-A-RAD PORTA RAD TABLE (November 24, 1992)
  • K923775 — R-MADE HEAD/ARM SUPPORT (October 20, 1992)
  • K920729 — BUCKY TABLE BK-12 (April 27, 1992)
  • K914351 — CLINITRON C-10 (February 14, 1992)

FDA data resources