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FDA 510(k)

FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM

K-Number: K003837 · 2001-03-12

ApplicantGe Oec Medical Systems
Decision Date2001-03-12
Product CodeOXO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ge Oec Medical Systems. It received FDA 510(k) clearance on 2001-03-12 under 510(k) number K003837. The device is classified under product code OXO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM?

FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 2001-03-12. The listed applicant is Ge Oec Medical Systems. The 510(k) number is K003837.

When did FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM receive FDA 510(k) clearance?

FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM received FDA 510(k) clearance on 2001-03-12, under 510(k) number K003837.

Who is the listed applicant for FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM?

The FDA 510(k) record lists Ge Oec Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM?

The FDA product code for FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM is OXO.

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Other records listing Ge Oec Medical Systems as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K073543OEC 9900 ELITEK0619539900 PLUS MOBILE FLUOROSCOPY SYSTEM WITH 3D AND NAVIGATION OPTIONSK052039GE OEC ALTITUDEK024012OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEMK022069OEC FLUOROTRAK 9800 PLUSK021049OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM

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Related Devices (Code: OXO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253296Digital C-ARM with 3DAllengers Medical Systems LimitedK252579Orthoscan TAU MVP Mini C-Arm SystemZiehm-Orthoscan, Inc.K253269OEC One CFDGe Hualun Medical Systems Co. , Ltd.K251004Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)Hefei Chimed Intelligent Machine Co., Ltd.K250587Orthoscan TAU Mini C-ArmZiehm-Orthoscan, Inc.K243452Orthoscan VERSA Mini C-ArmZiehm-Orthoscan, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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