SK S-RAY GRIDS— 510(k) K945697

Substantially Equivalent

Seibu Techno Coproration

FDA 510(k) clearance K945697 for SK S-RAY GRIDS, Substantially Equivalent on 1995-01-31. Applicant: Seibu Techno Coproration. Device class: 1.

Clearance details

Applicant: Seibu Techno Coproration
Product code: Code IXJ
Device class: Class 1
Regulation: 21 CFR 892.1910
Advisory panel: Radiology
Date received: 1994-11-17
Decision date: 1995-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Japan, JP

Download summary PDF View on FDA.gov ↗

Recent devices under product code IXJ

K964025 — MITAYA ALUMINUM INTERSPACED X-RAY GRID1997-06-13
K963893 — FIBRE INTERSPACED X-RAY GRID1996-11-07
K962338 — RADIOGRAPHIC GRID1996-07-03
K954294 — HIGH TRANSMISSION CELLULAR (HTC) GRIDS 18X24 CM & 24X30 CM SIZES1996-02-02
K945327 — JPI X-RAY GRID1995-01-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.