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FDA 510(k)

SERIES 6600 DIGITAL MOBILE C-ARM

K-Number: K951765 · 1995-05-11

ApplicantGe Dec Medical Systems
Decision Date1995-05-11
Product CodeOXO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SERIES 6600 DIGITAL MOBILE C-ARM is the device name listed in this FDA 510(k) record. The listed applicant is Ge Dec Medical Systems. It received FDA 510(k) clearance on 1995-05-11 under 510(k) number K951765. 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 SERIES 6600 DIGITAL MOBILE C-ARM?

SERIES 6600 DIGITAL MOBILE C-ARM is a medical device that received FDA 510(k) clearance on 1995-05-11. The listed applicant is Ge Dec Medical Systems. The 510(k) number is K951765.

When did SERIES 6600 DIGITAL MOBILE C-ARM receive FDA 510(k) clearance?

SERIES 6600 DIGITAL MOBILE C-ARM received FDA 510(k) clearance on 1995-05-11, under 510(k) number K951765.

Who is the listed applicant for SERIES 6600 DIGITAL MOBILE C-ARM?

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

What is the FDA product code for SERIES 6600 DIGITAL MOBILE C-ARM?

The FDA product code for SERIES 6600 DIGITAL MOBILE C-ARM is OXO.

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Other records listing Ge Dec 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.

K000221SERIES 7700 MOBILE C-ARM, COMPACT 7700 MOBILE C-ARM, COMPACT 7700 PLUS MOBILE C-ARMK993687UROVIEW 2800K992506MINI 6800 DIGITAL MOBILE C-ARMK974355INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED IMDIS)K970063SERIES 7600 MOBILE DIGITAL C-ARMK963952SERIES 9600 MOBILE DIGITAL IMAGING SYSTEM

View all 10 devices →

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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