Identifiers
- 510(k) Number
- K090972 FDA 510(k)
- FDA Product Code
- MUJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.5050 FDA 510(k)
- Regulation Number
- 892.5050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Leksell Gammaplan is a radiation therapy treatment planning system. It is classified as a Class II medical device under FDA regulation 892.5050 and is used in the field of radiology for treatment planning purposes.
The device received FDA 510(k) clearance (K090972) on July 20, 2009, as substantially equivalent to a predicate device. It is manufactured by Elekta Instrument AB in Stockholm, Sweden, and is supplied as a software system for use in clinical radiation therapy planning environments.
Frequently asked questions
What is the Leksell Gammaplan used for?
The Leksell Gammaplan is a radiation therapy treatment planning system used in the field of radiology for planning radiation therapy treatments, as specified in its FDA 510(k) clearance documentation.
How is the Leksell Gammaplan supplied and what type of device is it?
The Leksell Gammaplan is supplied as a software system for use in clinical radiation therapy planning environments and is classified as a Class II medical device under FDA regulation 892.5050.
What regulatory clearance does the Leksell Gammaplan have and when was it granted?
The Leksell Gammaplan received FDA 510(k) clearance (K090972) on July 20, 2009, as substantially equivalent to a predicate device, based on the data provided in its authorization record.
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: Leksell Vantage™ Stereotactic System | Neurosurgery | Elekta, Leksell Rongeur: Instrumente für die orthopädische Chirurgie
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K090972 | Class II | Active |
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Manufacturer
- Manufacturer
- Elekta Instrument AB
Sources (1)
- FDA 510(k) K090972 24 fields · synced Sep 23, 2026