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FDA 510(k)

INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED IMDIS)

K-Number: K974355 · 1998-02-17

ApplicantGe Dec Medical Systems
Decision Date1998-02-17
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED IMDIS) 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 1998-02-17 under 510(k) number K974355. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED IMDIS)?

INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED IMDIS) is a medical device that received FDA 510(k) clearance on 1998-02-17. The listed applicant is Ge Dec Medical Systems. The 510(k) number is K974355.

When did INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED IMDIS) receive FDA 510(k) clearance?

INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED IMDIS) received FDA 510(k) clearance on 1998-02-17, under 510(k) number K974355.

Who is the listed applicant for INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED IMDIS)?

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 INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED IMDIS)?

The FDA product code for INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED IMDIS) is OWB.

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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-ARMK970063SERIES 7600 MOBILE DIGITAL C-ARMK963952SERIES 9600 MOBILE DIGITAL IMAGING SYSTEMK950781COMPACT 7600

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Related Devices (Code: OWB)

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.

K253726uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.K261413EXTRON 3;EXTRON 6DRTECH CorporationK254205Zenition 30Philips Medical Systems Nederland B.V.K260607Shield System (Siemens 30x40)Radiaction , Ltd.K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.K252735C-beamPulmera, 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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