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V-MAX Options

FDA 510(k)

Class II (US FDA 510(k))

510(k) K943447

by Philips Medical Systems (Cleveland), Inc.

Identifiers

510(k) Number
K943447 FDA 510(k)
FDA Product Code
JAA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1650 FDA 510(k)
Regulation Number
892.1650 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

V-MAX Options is a fluoroscopic X-ray imaging system designed for radiology applications. It is classified as a Class II medical device under product code JAA and is substantially equivalent to predicate devices. The system is intended to provide real-time X-ray imaging for diagnostic procedures.

The device is manufactured by Philips Medical Systems (Cleveland), Inc. and was cleared under FDA 510(k) number K943447 with a traditional clearance type. It is subject to regulation 892.1650 and has been registered with numerous FEI numbers. Storage, sterility, and reuse status are not specified in the available data.

Frequently asked questions

What is the V-MAX OPTIONS used for?

The V-MAX OPTIONS is a fluoroscopic X-ray imaging system intended for radiology applications. It provides real-time X-ray imaging for diagnostic procedures, functioning as a Class II medical device under product code JAA.

Who manufactured the V-MAX OPTIONS?

The V-MAX OPTIONS was manufactured by Philips Medical Systems (Cleveland), Inc., located at 595 Miner Rd., Cleveland, OH 44143, United States.

What regulatory clearance does the V-MAX OPTIONS have?

The V-MAX OPTIONS received FDA 510(k) clearance under number K943447. The clearance was granted on November 28, 1994, with a decision code of SESE (Substantially Equivalent) and a traditional clearance type.

Is the V-MAX OPTIONS a single-use or reusable device?

The available device data does not specify whether the V-MAX OPTIONS is single-use or reusable, nor does it provide information on its sterility status. These details are not recorded in the regulatory filing.

What storage conditions are required for the V-MAX OPTIONS?

The device data does not include specific storage requirements for the V-MAX OPTIONS. No environmental or handling conditions are documented in the available regulatory records.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Philips V-Max Options - allmed.wiki, V-MAX OPTIONS (K943447) - FDA 510 (k), V-MAX OPTIONS 510 (k) K943447 - FDA.report, PDF K943447 - V-max Options, Philips Medical Systems (Cleveland), Inc. et al v. Buan et al, 1 ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Philips Medical Systems (Cleveland), Inc.

Sources (1)

  • FDA 510(k) K943447 24 fields · synced Oct 6, 2026