Dosimeter, Ionizing Radiation, Implanted

Device Code: 5402

Product Code(s): NZT

Definition: Verify Radiation Dose To Organs From External Radiation Therapy.

Device Classification Information

• Device Type ID: 5402
• Device Name: Dosimeter, Ionizing Radiation, Implanted
• Physical State: Glass Encapsulated Electronics
• Technical Method: Radiation Causes Change In MOSFET Diode That Is Perportional To Dose Which Can Be Interigated By External Reader.
• Target Area: Radiation Therapy Target Organ
• Regulation Description: Medical Charged-particle Radiation Therapy System.
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(k)
• CFR Regulation Number: 892.5050 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: NZT
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: Yes
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 12-217 IEC 62083 Edition 2.0 2009-09
  Medical Electrical Equipment - Requirements For The Safety Of Radiotherapy Treatment Planning Systems
• 12-267 IEC 61217 Edition 2.0 2011-12
  Radiotherapy Equipment - Coordinates, Movements, And Scales
• 12-285 IEC 60601-2-1 Edition 3.1 2014-07
  Medical Electrical Equipment - Part 2-1: Particular Requirements For The Basic Safety And Essential Performance Of Electron Accelerators In The Range 1 MeV To 50 MeV

Total Product Life Cycle

• Device Type ID: 5402
• Device: Dosimeter, Ionizing Radiation, Implanted
• Product Code: NZT
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Medical Charged-particle Radiation Therapy System.
• CFR Regulation Number: 892.5050 [🔎]

Premarket Reviews
Manufacturer	Decision
RADIADYNE
	SUBSTANTIALLY EQUIVALENT	1
RADIADYNE, LLC
	SUBSTANTIALLY EQUIVALENT	2

TPLC Last Update: 2019-04-02 21:05:36