System, Applicator, Radionuclide, Remote-controlled

Device Code: 5364

Product Code(s): JAQ

Device Classification Information

• Device Type ID: 5364
• Device Name: System, Applicator, Radionuclide, Remote-controlled
• Regulation Description: Remote Controlled Radionuclide Applicator 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: 892.5700 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: JAQ
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

• 12-259 IEC 61674 Edition 2.0 2012-11
  Medical Electrical Equipment -- Dosimeters With Ionization Chambers And/or Semiconductor Detectors As Used In X-ray Diagnostic Imaging
• 12-272 IEC 60601-2-17 Edition 3.0 2013-11
  Medical Electrical Equipment - Part 2-17: Particular Requirements For The Safety Of Automatically-controlled Brachytherapy Afterloading Equipment

Total Product Life Cycle

• Device Type ID: 5364
• Device: System, Applicator, Radionuclide, Remote-controlled
• Product Code: JAQ
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Remote Controlled Radionuclide Applicator System.
• CFR Regulation Number: 892.5700 [🔎]

Premarket Reviews
Manufacturer	Decision
BEST MEDICAL INTERNA
	SUBSTANTIALLY EQUIVALENT	1
C4 IMAGING LLC
	SUBSTANTIALLY EQUIVALENT	1
ECKERT & ZIEGLER BEBIG GMBH
	SUBSTANTIALLY EQUIVALENT	1
ELEKTA INC
	SUBSTANTIALLY EQUIVALENT	4
GC MEDTECH, LLC
	SUBSTANTIALLY EQUIVALENT	2
MICK RADIO-NUCLEAR INSTRUMENTS
	SUBSTANTIALLY EQUIVALENT	2
MICK RADIO-NUCLEAR INSTRUMENTS, INC.
	SUBSTANTIALLY EQUIVALENT	2
NUCLETRON
	SUBSTANTIALLY EQUIVALENT	6
NUCLETRON BV
	SUBSTANTIALLY EQUIVALENT	2
SPENCER FILLMORE
	SUBSTANTIALLY EQUIVALENT	1
VARIAN
	SUBSTANTIALLY EQUIVALENT	15
VARIAN MEDICAL SYSTEMS, INC
	SUBSTANTIALLY EQUIVALENT	21

Device Problems
Adverse Event Without Identified Device Or Use Problem	4
Use Of Device Problem	3
Improper Or Incorrect Procedure Or Method	3
Device Operates Differently Than Expected	2
Computer Software Problem	2
Labelling, Instructions For Use Or Training Problem	1
Off-Label Use	1
Total Device Problems	16

Recalls
Manufacturer		Recall Class	Date Posted
1	Varian Medical Systems Inc	II	Jun-26-2015
2	Varian Medical Systems Inc	II	Jun-23-2015

TPLC Last Update: 2019-04-02 21:04:58