Identifiers
- 510(k) Number
- K852768 FDA 510(k)
- FDA Product Code
- IZF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1740 FDA 510(k)
- Regulation Number
- 892.1740 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a System, X-Ray, Tomographic as defined in the nomenclature authority. It is a panoramic dental X-ray system designed for imaging the maxillofacial region.
It is supplied as a reusable system intended for use in radiology settings. The device received FDA 510(k) clearance under K852768 and is classified as a Class II medical device under regulation number 892.1740.
Frequently asked questions
What is the ORALIX PANORAMIC D.C. used for?
The ORALIX PANORAMIC D.C. is a panoramic dental X-ray system designed for imaging the maxillofacial region, enabling clinicians to capture comprehensive tomographic images of the upper and lower jaws, teeth, and surrounding structures for diagnostic evaluation in radiology settings.
How is the ORALIX PANORAMIC D.C. supplied and intended for use?
The device is supplied as a reusable system intended for use in radiology settings, meaning it is designed for repeated clinical use after appropriate cleaning and maintenance between patients, rather than as a single-use disposable product.
What regulatory clearance does the ORALIX PANORAMIC D.C. have?
The ORALIX PANORAMIC D.C. received FDA 510(k) clearance under submission number K852768, which confirms it is substantially equivalent to a legally marketed predicate device, and it is classified as a Class II medical device under regulation number 892.1740.
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 Oralix Panoramic D.C | allmed.wiki, Oralix Panoramic D.c. 510 (k) K852768 - FDA.report, PDF K852768 ORALIX PANORAMIC D.C. - 510kdatabase.net, FDA Browser - Cleared 510 (K) - ORALIX PANORAMIC D.C. (K852768)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K852768 | Class II | Active |
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Manufacturer
- Manufacturer
- Philips Medical Systems, Inc.
Sources (1)
- FDA 510(k) K852768 24 fields · synced Sep 24, 2026