Home / 510(k) Clearances / K934574

510(k) K934574

MODEL MPFT-01, GENESIS by International Medical Designs, Inc. — Product Code IXR

K934574 is an FDA 510(k) premarket notification submitted by International Medical Designs, Inc. for the device "MODEL MPFT-01, GENESIS". The FDA issued a decision of Substantially Equivalent on March 4, 1994. The device falls under product code IXR (Table, Radiographic, Tilting), a Class II device regulated under 21 CFR 892.1980. International Medical Designs, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1994
Date Received
September 16, 1993
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 International Medical Designs, Inc.

  • K942019 — MODEL FP-100 (February 1, 1995)

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