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FDA 510(k)

CS-SERIES-FP WITH 3030+OPTION

K-Number: K121293 · 2012-07-26

ApplicantOmega Medical Imaging, LLC
Decision Date2012-07-26
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CS-SERIES-FP WITH 3030+OPTION is the device name listed in this FDA 510(k) record. The listed applicant is Omega Medical Imaging, LLC. It received FDA 510(k) clearance on 2012-07-26 under 510(k) number K121293. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CS-SERIES-FP WITH 3030+OPTION?

CS-SERIES-FP WITH 3030+OPTION is a medical device that received FDA 510(k) clearance on 2012-07-26. The listed applicant is Omega Medical Imaging, LLC. The 510(k) number is K121293.

When did CS-SERIES-FP WITH 3030+OPTION receive FDA 510(k) clearance?

CS-SERIES-FP WITH 3030+OPTION received FDA 510(k) clearance on 2012-07-26, under 510(k) number K121293.

Who is the listed applicant for CS-SERIES-FP WITH 3030+OPTION?

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

What is the FDA product code for CS-SERIES-FP WITH 3030+OPTION?

The FDA product code for CS-SERIES-FP WITH 3030+OPTION is JAA.

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Other records listing Omega Medical Imaging, LLC 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.

K242488Soteria E-ViewK212890Nyquist.IQK212336Soteria.AIK191713CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly)K182834CS-series-FP with Optional ROI Accessory CA-100SK171755CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System

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Related Devices (Code: JAA)

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.

K253103Nexus DRF Digital X-ray Imaging SystemVarex Imaging CorporationK251650Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLCK242488Soteria E-ViewOmega Medical Imaging, LLCK242948Adora DRFi (04550010)Nrt X-Ray A/SK233380TRIDENT Mobile Fluoroscopy SystemDornier Medtech AmericaK233945ProxiDiagnost N90 / Precision CRF (706110, 706400)Philips Medical Systems Dmc GmbH

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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