Identifiers
- 510(k) Number
- K010435 FDA 510(k)
- FDA Product Code
- OWB 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)
The Philips Bv Pulsera/Endura is an Interventional Fluoroscopic X-Ray System, which is a type of device that visualizes anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. It is used in the field of Radiology.
The device is supplied by Philips Medical Systems, Inc. and has been authorized with an FDA 510(k) clearance. It is classified under the regulation number 892.1650 and has a product code of OWB. The device is intended for use in medical settings and is subject to specific storage and handling requirements.
Frequently asked questions
What is the Philips Bv Pulsera/Endura used for?
The Philips Bv Pulsera/Endura is used for visualizing anatomical structures in medical settings, specifically in the field of Radiology.
Is the Philips Bv Pulsera/Endura cleared by the FDA?
Yes, the Philips Bv Pulsera/Endura has been authorized with an FDA 510(k) clearance, indicating it is substantially equivalent to a predicate device.
What are the storage and handling requirements for the Philips Bv Pulsera/Endura?
The device is subject to specific storage and handling requirements, which are not detailed in the provided information, but are typically outlined in the device's user manual or manufacturer's instructions.
What type of device is the Philips Bv Pulsera/Endura?
The Philips Bv Pulsera/Endura is an Interventional Fluoroscopic X-Ray System, which converts a pattern of x-radiation into a visible image through electronic amplification.
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 BV PULSERA/ENDURA (K010435) — FDA 510(k) | Innolitics, PHILIPS BV PULSERA/ENDURA by PHILIPS MEDICAL SYSTEMS, INC. | FDA 510 (k ..., PHILIPS BV PULSERA/ENDURA 510 (k) K010435 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K010435 | Class II | Active |
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Manufacturer
- Manufacturer
- Philips Medical Systems, Inc.
Sources (1)
- FDA 510(k) K010435 24 fields · synced Sep 21, 2026