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510(k) K853175

REI-90/15 by Radiological Engineering, Inc. — Product Code IXR

K853175 is an FDA 510(k) premarket notification submitted by Radiological Engineering, Inc. for the device "REI-90/15". The FDA issued a decision of Substantially Equivalent on October 10, 1985. The device falls under product code IXR (Table, Radiographic, Tilting), 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
October 10, 1985
Date Received
July 30, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Radiographic, Tilting
Device Class
Class II
Regulation Number
892.1980
Review Panel
RA
Submission Type

Other clearances by Radiological Engineering, Inc.

  • K873702 — REI-38 RADIOGRAPHIC TABLE (April 22, 1988)
  • K854478 — REI-90/90 RADIOGRAPHIC TABLE (April 17, 1986)
  • K853210 — MST-1050-II X-RAY UNIT (October 10, 1985)

Other clearances for product code IXR

  • K000412 — VISION R/F TILTING TABLE (April 24, 2000)
  • K973039 — LEGACY/LEGACY-D TABLE (October 16, 1997)
  • K971128 — CAP-35B III/CINE 275 (April 28, 1997)
  • K970640 — PHILIPS EASY DIAGNOST (March 21, 1997)
  • K965105 — ELECTROPHYSIOLOGY TILT TABLE MODEL #9660 (January 30, 1997)
  • K965096 — FLUOROVIEW SERIES FLUOROSCOPIC TABLES (January 27, 1997)
  • K963851 — TILTING RADIOGRAPHIC TABLE (REMOTE) (January 23, 1997)
  • K961022 — TANGENT VI TABLE (May 3, 1996)
  • K954356 — COMPAX 90/15E (October 7, 1995)
  • K953556 — VACS TABLE, 9650 (September 26, 1995)

FDA data resources