Device, Spot-Film
FDA product code IXL · Class II (moderate risk) · 21 CFR 892.1670 · Radiology
13510(k) clearances
0PMA approvals
3recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K111304 | Optima XR120IXL · Special | Ge Medical Systems, LLC | 07/19/2011SE |
| 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 |
| K902146 | SFD-035 Spot Film DeviceIXL · Traditional | Rms Div. | 05/31/1990SE |
| 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 |
| K802888 | Raytheon Medical ImagingIXL · Traditional | Machlett Laboratories, Inc. | 01/09/1981SE |
| K800554 | Multi-Format SFD Model 1720IXL · Traditional | Philips Medical Systems (Cleveland), Inc. | 04/10/1980SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1605-2011 | Philips BV Pulsera, Rel. 2.3, 718095. Mobile C-Arm X-Ray systems offering Radiographic…The fixing strap of the belt holding the CBX Laser to the Image Intensifier may be detached during a… | Philips Medical Systems North America Co.… | 12/14/2010Terminated |
| Z-1604-2011 | Philips BV Endura, Rel. 2, 718074. Mobile C-Arm X-Ray systems offering Radiographic and…The fixing strap of the belt holding the CBX Laser to the Image Intensifier may be detached during a… | Philips Medical Systems North America Co.… | 12/14/2010Terminated |
| Z-2404-2010 | Diagnost 56/66/76/76 Plus, DSI is a Spot-Film and has a Digital Imaging Spot. Intended…Potential for the tower (holding the serial changer and/or image intensifier) to slide unexpectedly and… | Philips Medical Systems North America Co.… | 01/04/2008Terminated |