Recognition List Number: 014 Publication Date: 03/31/2006
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 12-138: ISO 5799:1991, Photography -- Direct-exposing medical and dental radiographic film/process systems -- Determination of ISO speed and ISO average gradient. (Radiology)
Date of Standard: 1991. |
| Address of Standards Organization: |
| International Organization for Standardization (ISO)* |
| 1, Rue de Varembe |
| Case Postale 56 |
| CH 1211 Geneva 20, 0 |
|
SWITZERLAND
|
|
| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | |
|
|
| Devices Affected: |
| X-Ray Film and Processing Equipment |
|
| Processes Affected: |
|
| Type of Standard: |
| International, Vertical |
| Extent of Recognition: |
| Complete standard and any annexes |
|
| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §892.1840 |
Film, Radiographic |
Class 1 |
IWZ |
| §892.1840 |
Media, Reusable Image |
Class 1 |
LQA |
| |
|
| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
|
| FDA Technical Contact: |
| Robert Jennings |
| FDA/CDRH/OSEL |
| 10903 New Hampshire Avenue Building 62, Room 3102 |
| Silver Spring MD 20993 |
| 301/796-2539 |
| Email: robertj.jennings@fda.hhs.gov |
|
|
