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FDA 510(k)

CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System

K-Number: K171755 · 2018-02-09

ApplicantOmega Medical Imaging, LLC
Decision Date2018-02-09
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System is a medical device manufactured by Omega Medical Imaging, LLC. It received FDA 510(k) clearance on 2018-02-09 under approval number K171755. 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 with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System?

CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System is a medical device that received FDA 510(k) clearance on 2018-02-09. It is manufactured by Omega Medical Imaging, LLC. The 510(k) number is K171755.

When was CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System approved by the FDA?

CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System received FDA 510(k) clearance on 2018-02-09, under approval number K171755.

What company makes CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System?

CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System is manufactured by Omega Medical Imaging, LLC.

What is the FDA product code for CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System?

The FDA product code for CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System is OWB.

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Related PubMed Literature

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Other Devices by Omega Medical Imaging, LLC

K191713CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly) K182834CS-series-FP with Optional ROI Accessory CA-100S K212890Nyquist.IQ K212336Soteria.AI K242488Soteria E-View

Related Devices (Code: OWB)

K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V. K162148Allura Xper R9Philips Medical Systems Nethrlands BV K162614Infinix, INFX-8000V, V6.35Toshibamedical Systems Corporation K160279ANYVIEW-500R Fluoroscopic Mobile X-Ray SystemEcotron Co., Ltd. K161976Ziehm Solo FDZiehm Imaging GmbH K161756SyncVision SystemVolcano Corporation

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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