Camera, Scintillation (gamma)

Device Code: 5334

Product Code(s): IYX

Device Classification Information

• Device Type ID: 5334
• Device Name: Camera, Scintillation (gamma)
• Regulation Description: Scintillation (gamma) Camera.
• 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: 892.1100 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: IYX
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Program

Recognized Standards

• 12-284 NEMA NU 1-2012
  Performance Measurements Of Gamma Cameras

Total Product Life Cycle

• Device Type ID: 5334
• Device: Camera, Scintillation (gamma)
• Product Code: IYX
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Scintillation (gamma) Camera.
• CFR Regulation Number: 892.1100 [🔎]

Premarket Reviews
Manufacturer	Decision
GE HEALTHCARE
	SUBSTANTIALLY EQUIVALENT	1
GENERAL ELECTRIC CO.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Use Of Device Problem	4
Adverse Event Without Identified Device Or Use Problem	2
Device Handling Problem	1
Mechanical Problem	1
Total Device Problems	8

Recalls
Manufacturer		Recall Class	Date Posted
1	Siemens Medical Solutions USA, Inc.	II	Sep-08-2016

TPLC Last Update: 2019-04-02 21:04:30