Cs-Series-Fp

FDA 510(k) K100102 · Omega Medical Imaging, Inc.

Substantially Equivalent

510(k) numberK100102

Submission

Device name
Cs-Series-Fp
Applicant
Omega Medical Imaging, Inc.
Sanford, FL, US
Received
January 13, 2010
Decision date
August 31, 2010
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OWB – Interventional Fluoroscopic X-Ray System
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1650
Specialty
Radiology

Interventional fluoroscopy

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K253670SmartCT (R3.0 (L10))OWB · Abbreviated Philips Medical Systems B.V.07/10/2026SE
K252735C-beamOWB · Traditional Pulmera, Inc.05/22/2026SE
K252503Intelligent NROWB · Traditional Canon, Inc.04/30/2026SE
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K252229Belliger AceOWB · Traditional Genoray Co., Ltd.04/02/2026SE

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K191713CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™…JAA · Traditional 10/04/2019SE
K182834CS-series-FP with Optional ROI Accessory CA-100SJAA · Traditional 03/29/2019SE
K171755CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy SystemOWB · Special 02/09/2018SE
K121293Cs-Series-Fp with 3030+OPTIONJAA · Traditional 07/26/2012SE
K093572R650 Qdasm CollimatorIZW · Traditional 02/03/2010SE
K070834Cs-Series Fluoroscopy System, CS-10 Through CS-65 (11 Configurations)OWB · Traditional 05/18/2007SE
K062647E-View Fluoroscopy System, Model CS-50OWB · Traditional 10/20/2006SE

Questions and answers

When was Cs-Series-Fp cleared by the FDA?

Cs-Series-Fp (K100102) received a 510(k) decision of Substantially Equivalent on August 31, 2010, 230 days after the submission was received.

What is the product code of K100102?

The FDA product code is OWB – Interventional Fluoroscopic X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1650.