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510(k) K942190

ID100 MOBILE FLUOROSCOPIC EXAMINING TABLE by Image Diagnostics, Inc. — Product Code IXQ

K942190 is an FDA 510(k) premarket notification submitted by Image Diagnostics, Inc. for the device "ID100 MOBILE FLUOROSCOPIC EXAMINING TABLE". The FDA issued a decision of Substantially Equivalent on August 17, 1994. The device falls under product code IXQ (Table, Radiographic, Stationary Top), a Class II device regulated under 21 CFR 892.1980. Image Diagnostics, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 1994
Date Received
May 4, 1994
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 Image Diagnostics, Inc.

  • K950631 — ID400 SERIES ARMBOARDS (March 24, 1995)
  • K944772 — MULTIPLE ED1600 SERIES RADIATION SHIELDS (October 20, 1994)

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)
  • 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)
  • K912382 — MILITARY RADIOGRAPHIC FLAT TABLE, CAT # T-9130 (October 10, 1991)

FDA data resources