Rotolux, Selectolux, Shuttervue
FDA 510(k) K922079 · American Medical Sales, Inc.
510(k) numberK922079
Submission
- Device name
- Rotolux, Selectolux, Shuttervue
- Applicant
- American Medical Sales, Inc.
Culver City, CA, US - Received
- May 4, 1992
- Decision date
- June 16, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code IXC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K991302 | Smartlight Digital Film Viewer, Models SL 4000PLUS, SL 2000PLUSIXC · Traditional | Smartlight, Inc. | 06/01/1999SE |
| K973965 | Smart Motorized ViewerIXC · Traditional | Smartlight, Ltd. | 12/12/1997SE |
| K973115 | Arripro 35 St/TvIXC · Traditional | Arnold & Richter Cine Technik | 09/02/1997SE |
| K970240 | Diffuser PanelIXC · Traditional | Focused Viewer, Inc. | 03/11/1997SE |
| K954998 | Lily Dark ViewerIXC · Traditional | Lily Imaging Solutions Co. | 01/29/1996SE |
| K954199 | VoxboxIXC · Traditional | Voxel | 09/29/1995SE |
| K952188 | Adviewer 2000IXC · Traditional | Adp , Ltd. | 05/30/1995SE |
| K922848 | Ultralite X-Ray Film IlluminatorIXC · Traditional | A & S Trading Co. | 09/28/1992SE |
| K883702 | Excelview IlluminatorIXC · Traditional | Excel Medical Products, Inc. | 09/19/1988SE |
| K875233 | Variviewer (X-Ray Film Viewer)IXC · Traditional | Diversified Diagnostic Products, Inc. | 01/19/1988SE |
More from Diversified Diagnostic Products, Inc.
Questions and answers
When was Rotolux, Selectolux, Shuttervue cleared by the FDA?
Rotolux, Selectolux, Shuttervue (K922079) received a 510(k) decision of Substantially Equivalent on June 16, 1992, 43 days after the submission was received.
What is the product code of K922079?
The FDA product code is IXC – Illuminator, Radiographic-Film, a Class I (low risk) device regulated under 21 CFR 892.1890.