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510(k) K883527

GRID/RADIOGRAPHIC by Umi, Inc. — Product Code IXJ

K883527 is an FDA 510(k) premarket notification submitted by Umi, Inc. for the device "GRID/RADIOGRAPHIC". The FDA issued a decision of Substantially Equivalent on September 2, 1988. The device falls under product code IXJ (Grid, Radiographic), a Class I device regulated under 21 CFR 892.1910. Umi, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 1988
Date Received
August 18, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Grid, Radiographic
Device Class
Class I
Regulation Number
892.1910
Review Panel
RA
Submission Type

Other clearances by Umi, Inc.

  • K831412 — CRM-100 COLOR VIDEO CAMERA (June 3, 1983)
  • K830924 — CRM-114 COLOR VIDEO CAMERA (April 18, 1983)
  • K823382 — NEPHROSTOMY CATHETER (January 28, 1983)

Other clearances for product code IXJ

  • K964025 — MITAYA ALUMINUM INTERSPACED X-RAY GRID (June 13, 1997)
  • K963893 — FIBRE INTERSPACED X-RAY GRID (November 7, 1996)
  • K962338 — RADIOGRAPHIC GRID (July 3, 1996)
  • K954294 — HIGH TRANSMISSION CELLULAR (HTC) GRIDS 18X24 CM & 24X30 CM SIZES (February 2, 1996)
  • K945697 — SK S-RAY GRIDS (January 31, 1995)
  • K945327 — JPI X-RAY GRID (January 20, 1995)
  • K941626 — GRIDGIL (May 13, 1994)
  • K940309 — X-RAY GRID (RADIOLOGICAL GRID) (April 22, 1994)
  • K926445 — SOYEE ALUMINUM INTERSPACED X-RAY GRID (April 7, 1993)
  • K926261 — JPI ALUMINUM INTERSPACED X-RAY GRID (March 18, 1993)

FDA data resources