Processor, Radiographic-film, Automatic

Device Code: 5315

Product Code(s): IXW

Device Classification Information

• Device Type ID: 5315
• Device Name: Processor, Radiographic-film, Automatic
• Regulation Description: Automatic Radiographic Film Processor.
• 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: 892.1900 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: IXW
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Program

Recognized Standards

• 12-137 ISO 4090 Third Eidition 2001-08-15
  Photography - Medical Radiographic Cassette/screens/films And Hard-copy Imaging Films - Dimensions And Specifications

Total Product Life Cycle

• Device Type ID: 5315
• Device: Processor, Radiographic-film, Automatic
• Product Code: IXW
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Automatic Radiographic Film Processor.
• CFR Regulation Number: 892.1900 [🔎]

Device Problems
Electrical /Electronic Property Problem	2
Use Of Device Problem	2
Smoking	1
Display Difficult To Read	1
Fire	1
Electrical Shorting	1
Device Handling Problem	1
Thermal Decomposition Of Device	1
Total Device Problems	10

Recalls
Manufacturer		Recall Class	Date Posted
1	Fujifilm Medical Systems U.S.A., Inc.	II	May-03-2016

TPLC Last Update: 2019-04-02 21:04:11