SFD-035 Spot Film Device
FDA 510(k) K902146 · Rms Div.
510(k) numberK902146
Submission
- Device name
- SFD-035 Spot Film Device
- Applicant
- Rms Div.
Addison, IL, US - Received
- May 14, 1990
- Decision date
- May 31, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K964806 | MD-1835IXL · Traditional | Fischer Imaging Corp. | 03/04/1997SE |
| K950317 | Advantx 1824 Spotfilm DeviceIXL · Traditional | GE Medical Systems | 02/08/1995SE |
| K940386 | Kodak Automixer III Integrated, Kodak Automixer III 180 LPIXL · Traditional | Eastman Kodak Company | 08/17/1994SE |
| K942367 | Axt 1400 Spotfilm DeviceIXL · Traditional | Applied X-Ray Technologies, Inc. | 06/06/1994SE |
| K924593 | Diagnost 76 Family*R/F Systems - Release 4.4IXL · Traditional | Philips Medical Systems, Inc. | 11/24/1992SE |
| K902403 | Elite R/F Spot Film DriveIXL · Traditional | Rms Div. | 08/01/1990SE |
| K882492 | A.X.T. Spotfilm DeviceIXL · Traditional | Applied X-Ray Technologies, Inc. | 07/21/1988SE |
| K881589 | 14X14 Multiformat Spot Filmer, No. 6650.400IXL · Traditional | Continental X-Ray Corp. | 07/18/1988SE |
| K842184 | Spot-Film Device 8835IXL · Traditional | General Electric Co. | 07/17/1984SE |
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| K944557 | DW250 #91EJT · Traditional | 11/03/1994SE |
| K941625 | DW234 #29EJS · Traditional | 06/22/1994SE |
| K902403 | Elite R/F Spot Film DriveIXL · Traditional | 08/01/1990SE |
| K896665 | EXT-600 Table, Radiographic, ElevatingIZZ · Traditional | 01/22/1990SE |
| K896119 | RMS 90/15 Radiographic/Fluoroscopic Tilting TableIXR · Traditional | 11/27/1989SE |
| K896324 | Elite 1500 Radiographic Tilting TableIXR · Traditional | 11/21/1989SE |
Questions and answers
When was SFD-035 Spot Film Device cleared by the FDA?
SFD-035 Spot Film Device (K902146) received a 510(k) decision of Substantially Equivalent on May 31, 1990, 17 days after the submission was received.
What is the product code of K902146?
The FDA product code is IXL – Device, Spot-Film, a Class II (moderate risk) device regulated under 21 CFR 892.1670.