SHIMADZU COLLIMATOR R-20J— 510(k) K101036

Substantially Equivalent

Shimadzu Corp.

FDA 510(k) clearance K101036 for SHIMADZU COLLIMATOR R-20J, Substantially Equivalent on 2010-08-26. Applicant: Shimadzu Corp.. Device class: 2.

Clearance details

Applicant: Shimadzu Corp.
Product code: Code IZX
Device class: Class 2
Regulation: 21 CFR 892.1610
Advisory panel: Radiology
Date received: 2010-04-14
Decision date: 2010-08-26
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Torrance, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IZX

K110856 — RALCO2011-08-10
K042840 — SHIMADZU COLLIMATOR R-20J2004-12-03
K031771 — SHIMADZU COLLIMATOR R-30H2003-08-21
K981267 — FACTS MONOBLOCK1998-05-06
K974240 — LIGHTLINE-M1997-12-22

More clearances from Shimadzu Corp.

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K101039 — SHIMADZU COLLIMATOR R-3002010-09-20
K090578 — SHIMADZU COLLIMATOR R-30H2009-11-06
K090268 — SHIMADZU MOBILE X-RAY SYSTEM MOBILE ART EVOLUTION2009-06-30

Recalls naming K101036

K-number listed on FDA's recall record

Z-0261-2013 — R-20J , Diagnostic X-Ray Beam-Limiting Device. In combination with any of below X-Ray tubes: 06/1.2P364DK-85, 0.6/1.2P324DK-125, 06/1.2P324DK-85, 0.6/1.2P38DE-85. Product Usage: The device is the beam-limiting device for X-ray Radiography.Class II·Terminated·Shimadzu Medical Systems·20111028

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K101036.

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