E.CAM EXTRA HIGH ENERGY COLLIMATOR— 510(k) K982387

Name: FDA 510(k) clearance K982387
Creator: U.S. Food and Drug Administration
Published: 1998-10-06

Substantially Equivalent

Siemens Medical Solutions USA, Inc.

FDA 510(k) clearance K982387 for E.CAM EXTRA HIGH ENERGY COLLIMATOR, Substantially Equivalent on 1998-10-06. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.

Clearance details

Applicant: Siemens Medical Solutions USA, Inc.
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 1998-07-09
Decision date: 1998-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hoffman Estates, IL, US

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Recalls naming K982387

K-number listed on FDA's recall record

Z-0914-2015 — e.cam -emission computed tomography system Used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.Class II·Terminated·Siemens Medical Solutions USA, Inc.·20140408

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K982387.

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Clearance details

Recent devices under product code KPS

More clearances from Siemens Medical Solutions USA, Inc.

Recalls naming K982387