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FDA 510(k)

OEC 902, 901 NASA II, OEC 902, 901 NASA I CCD C-ARM

K-Number: K955251 · 1996-04-12

ApplicantImaging Services, Inc.
Decision Date1996-04-12
Product CodeOXO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OEC 902, 901 NASA II, OEC 902, 901 NASA I CCD C-ARM is the device name listed in this FDA 510(k) record. The listed applicant is Imaging Services, Inc.. It received FDA 510(k) clearance on 1996-04-12 under 510(k) number K955251. 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 OEC 902, 901 NASA II, OEC 902, 901 NASA I CCD C-ARM?

OEC 902, 901 NASA II, OEC 902, 901 NASA I CCD C-ARM is a medical device that received FDA 510(k) clearance on 1996-04-12. The listed applicant is Imaging Services, Inc.. The 510(k) number is K955251.

When did OEC 902, 901 NASA II, OEC 902, 901 NASA I CCD C-ARM receive FDA 510(k) clearance?

OEC 902, 901 NASA II, OEC 902, 901 NASA I CCD C-ARM received FDA 510(k) clearance on 1996-04-12, under 510(k) number K955251.

Who is the listed applicant for OEC 902, 901 NASA II, OEC 902, 901 NASA I CCD C-ARM?

The FDA 510(k) record lists Imaging Services, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OEC 902, 901 NASA II, OEC 902, 901 NASA I CCD C-ARM?

The FDA product code for OEC 902, 901 NASA II, OEC 902, 901 NASA I CCD C-ARM is OXO.

Other records listing Imaging Services, Inc. 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.

K010772ISI-2500 CCD C-ARM, ISI-2500 PLUS CCD C-ARM

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

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

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