Film, Radiographic

Device Code: 5301

Product Code(s): IWZ

Device Classification Information

• Device Type ID: 5301
• Device Name: Film, Radiographic
• Regulation Description: Radiographic Film.
• 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: 892.1840 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: IWZ
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 12-136 ISO 9236-1 Second Edition 2004-02-01
  Photography - Sensitometry Of Screen/film Systems For Medical Radiography - Part 1: Determination Of Sensitometric Curve Shape, Speed And Average Gradient
• 12-137 ISO 4090 Third Eidition 2001-08-15
  Photography - Medical Radiographic Cassette/screens/films And Hard-copy Imaging Films - Dimensions And Specifications
• 12-138 ISO 5799 Second Edition 1991-08-01
  Photography -- Direct-exposing Medical And Dental Radiographic Film/process Systems -- Determination Of ISO Speed And ISO Average Gradient

Total Product Life Cycle

• Device Type ID: 5301
• Device: Film, Radiographic
• Product Code: IWZ
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Radiographic Film.
• CFR Regulation Number: 892.1840 [🔎]

Recalls
Manufacturer		Recall Class	Date Posted
1	AGFA Corp.	III	Jun-26-2015
2	AGFA Healthcare Corp.	III	Dec-16-2014
3	AGFA Healthcare Corp.	III	Aug-10-2014
4	Agfa N.V.	III	Mar-21-2019
5	Carestream Health Inc.	III	Aug-01-2014

TPLC Last Update: 2019-04-02 21:03:57