IntraSight Plus
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- IntraSight Plus EUDAMED
- Device Name
- IntraSight Plus EUDAMED
- Model / Reference
- 797423 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00845225012946 EUDAMED
- Basic UDI-DI
- 08452250BM1872ZA EUDAMED
- Direct Marketing DI
- 00845225012946 EUDAMED
- 510(k) Number
- K253714 FDA 510(k)
- FDA Product Code
- IYO FDA 510(k)
- EMDN Code
- C010499 ANGIOGRAPHY AND HEMODYNAMICS DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1560 FDA 510(k)
- Regulation Number
- 892.1560 FDA 510(k)
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
The IntraSight Plus is a fluoroscopy-guided surgical navigation system designed for real-time imaging and precise localization during orthopaedic procedures. It combines X-ray imaging with advanced tracking technology to enhance surgical accuracy, particularly in procedures requiring intra-operative alignment or fixation, such as spinal or joint surgeries.
This device is supplied as a reusable system and is intended for use in sterile operating room environments. It is classified under the MDR and FDA 510K pathway with a traditional review process, ensuring compliance with regulatory standards for medical imaging equipment. The system is not MRI-compatible and requires proper calibration and maintenance as specified by the manufacturer.
Frequently asked questions
What types of orthopaedic procedures is the IntraSight Plus designed to assist with, and how does it improve surgical accuracy?
The IntraSight Plus is specifically designed for fluoroscopy-guided surgical navigation during orthopaedic procedures that require real-time imaging and precise localization, such as spinal surgeries or joint alignments. It combines X-ray imaging with advanced tracking technology to enhance accuracy by providing continuous visualization of surgical instruments and implants, reducing the risk of misalignment or improper placement during procedures.
Is the IntraSight Plus system reusable, and if so, what considerations should be taken into account for its use in sterile environments?
Yes, the IntraSight Plus is supplied as a reusable system, meaning it is intended for repeated use in clinical settings. Since it is designed for sterile operating room environments, proper cleaning, sterilization, and maintenance protocols must be followed as outlined by Philips to ensure sterility and functionality between uses. This includes adherence to manufacturer guidelines for calibration and upkeep.
What regulatory pathways does the IntraSight Plus follow, and how does this impact its use in clinical settings?
The IntraSight Plus has undergone regulatory review through both the FDA’s 510(k) pathway and the EU’s Medical Device Regulation (MDR), with a traditional review process for the FDA. This ensures compliance with stringent safety and performance standards for medical imaging equipment. Clinicians can rely on its regulatory clearance to confirm that the device meets established guidelines for use in fluoroscopy-guided orthopaedic procedures.
Can the IntraSight Plus be used in an MRI environment, and what compatibility considerations should be noted?
No, the IntraSight Plus is explicitly stated as not MRI-compatible. This means it should never be used in or near an MRI scanner, as the electromagnetic fields generated by MRI systems could interfere with the device’s functionality or pose safety risks. Clinicians must ensure the device is used only in non-MRI environments and follow manufacturer guidelines for safe operation.
How is the IntraSight Plus system maintained, and what role does calibration play in ensuring its accuracy during procedures?
The IntraSight Plus requires proper calibration and maintenance as specified by Philips to sustain its precision and reliability. Regular calibration ensures the tracking technology and imaging components remain accurate, which is critical for real-time surgical navigation. Clinics should follow the manufacturer’s maintenance schedule and protocols to avoid performance degradation, particularly in procedures where alignment or fixation accuracy is paramount.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K253714 | Class II | Active |
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Manufacturer
- Manufacturer
- Philips Image Guided Therapy Corporation
Sources (2)
- FDA 510(k) K253714 24 fields · synced Sep 18, 2026
- EUDAMED bf4e3468-5ef7-4712-9e47-b920ac6d640b 61 fields · synced Jul 11, 2026