Neurosurgical Laser With Mr Thermography

Product Code: ONO

General & Plastic Surgery Medical Laser Products

Definition: Laser Device For Use To Necrotize Or Coagulate Soft Tissue Through Interstitial Irradition Or Thermal Therapy Under Mri Guidance And Real Time Mr Thermography In Neurosurgery.

Applicable Standards: Laser Products. [1040.10] Specific Purpose Laser Products. [1040.11]

Code of Federal Regulations: 878.4810


Radiation TypeOptical
Radition SafetyProduct
Annual ReportsYes

Products Classified as ONO

3825Neurosurgical Laser With Mr ThermographyLaser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology.

Total Product Life Cycle (TPLC) Devices

3825Neurosurgical Laser With Mr ThermographyLaser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology.

FDA Consensus Standards

Neurosurgical Laser With Mr Thermography [30278]21 CFR §878.4810 🔎
Neurosurgical Laser With Mr Thermography [38651]21 CFR §878.4810 🔎
Neurosurgical Laser With Mr Thermography [38649]21 CFR §878.4810 🔎
Neurosurgical Laser With Mr Thermography [38650]21 CFR §878.4810 🔎
Neurosurgical Laser With Mr Thermography [34006]21 CFR §878.4810 🔎

Pre-market Notifications for ONO

K214125TRANBERG Thermoguide Therapy SystemClinical Laserthermia Systems AB
K211269Visualase MRI-Guided Laser Ablation System (SW 3.4)Medtronic Navigation, Inc.

Global Unique Device Identification Database

17340007000888Neurosurgical Laser With Mr Thermography
17340007000871Neurosurgical Laser With Mr Thermography
37340007000868Neurosurgical Laser With Mr Thermography
37340007000851Neurosurgical Laser With Mr Thermography
37340007000844Neurosurgical Laser With Mr Thermography
17340007000833Neurosurgical Laser With Mr Thermography
17340007000826Neurosurgical Laser With Mr Thermography
00763000357504Neurosurgical laser with MR thermography
00763000313364Neurosurgical laser with MR thermography
37340007000950Neurosurgical Laser With Mr Thermography
00763000521370Neurosurgical laser with MR thermography

Maude Adverse Events

THERMOGRAMUNK2017-05-11

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