Table, Radiologic

Device Code: 5378

Product Code(s): KXJ

Device Classification Information

• Device Type ID: 5378
• Device Name: Table, Radiologic
• Regulation Description: Radiologic Table.
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 892.1980 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: KXJ
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 12-296 IEC 60601-2-54 CONSOLIDATED VERSION Edition 1.1 2015-04
  Medical Electrical Equipment - Part 2-54: Particular Requirements For The Basic Safety And Essential Performance Of X-ray Equipment For Radiography And Radioscopy
• 12-317 IEC 60601-2-54 CONSOLIDATED VERSION Edition 1.1 2015-04
  Medical Electrical Equipment - Part 2-54: Particular Requirements For The Basic Safety And Essential Performance Of X-ray Equipment For Radiography And Radioscopy [Including: Amendment 2 (2018)]

Total Product Life Cycle

• Device Type ID: 5378
• Device: Table, Radiologic
• Product Code: KXJ
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Radiologic Table.
• CFR Regulation Number: 892.1980 [🔎]

Device Problems
Unintended Movement	5
Fluid Leak	4
Mechanical Problem	3
Hydraulic System	2
Unintended System Motion	2
Table	1
Controller	1
Detachment Of Device Or Device Component	1
Loose Or Intermittent Connection	1
Total Device Problems	20

Recalls
Manufacturer		Recall Class	Date Posted
1	Deerfield Imaging, Inc.	II	Mar-13-2018
2	Villa Radiology Systems LLC	II	Jan-20-2017
3	Villa Radiology Systems LLC	II	Mar-06-2015
4	Villa Sistemi Medicali S.P.A.	II	Mar-09-2017

TPLC Last Update: 2019-04-02 21:05:10