FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READER

Solid State X-ray Imager (flat Panel/digital Imager)

FUJIFILM MEDICAL SYSTEM U.S.A., INC.

The following data is part of a premarket notification filed by Fujifilm Medical System U.s.a., Inc. with the FDA for Fuji Computed Radiography (fcr) Clearview Cs Image Reader.

Pre-market Notification Details

• Device ID: K042023
• 510k Number: K042023
• Device Name: FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READER
• Classification: Solid State X-ray Imager (flat Panel/digital Imager)
• Applicant: FUJIFILM MEDICAL SYSTEM U.S.A., INC. 419 WEST AVE. Stamford, CT 06902
• Contact: Frank Gianelli
• Correspondent: Jeffery Rongero; UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709
• Product Code: MQB
• CFR Regulation Number: 892.1680 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2004-07-28
• Decision Date: 2004-08-25
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04547410049213	K042023	000
14547410049562	K042023	000
14547410049708	K042023	000
14547410049715	K042023	000
14547410049722	K042023	000
14547410049739	K042023	000
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14547410049531	K042023	000
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14547410049470	K042023	000
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14547410049517	K042023	000
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14547410211273	K042023	000
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14547410211297	K042023	000
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