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FDA 510(k)

CS-SERIES-FP

K-Number: K100102 · 2010-08-31

ApplicantOmega Medical Imaging, Inc.
Decision Date2010-08-31
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CS-SERIES-FP is the device name listed in this FDA 510(k) record. The listed applicant is Omega Medical Imaging, Inc.. It received FDA 510(k) clearance on 2010-08-31 under 510(k) number K100102. 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 CS-SERIES-FP?

CS-SERIES-FP is a medical device that received FDA 510(k) clearance on 2010-08-31. The listed applicant is Omega Medical Imaging, Inc.. The 510(k) number is K100102.

When did CS-SERIES-FP receive FDA 510(k) clearance?

CS-SERIES-FP received FDA 510(k) clearance on 2010-08-31, under 510(k) number K100102.

Who is the listed applicant for CS-SERIES-FP?

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

What is the FDA product code for CS-SERIES-FP?

The FDA product code for CS-SERIES-FP is OWB.

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Other records listing Omega Medical Imaging, 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.

K093572R650 QDASM COLLIMATORK070834CS-SERIES FLUOROSCOPY SYSTEM, CS-10 THROUGH CS-65 (11 CONFIGURATIONS)K062647E-VIEW FLUOROSCOPY SYSTEM, MODEL CS-50K050092R605 FACS COLLIMETERK990055B-400 CEILING MOUNTED POSSITIONER, MODEL B-400K970947B-350 CEILING MOUNTED C-POSITIONER

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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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