Summit Industries, Inc.
Medical device manufacturer in Chicago, IL.
8510(k) clearances
0PMA approvals
4recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K173823 | Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography…KPR · Traditional | 02/09/2018SE |
| K153119 | Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography…KPR · Traditional | 03/14/2016SE |
| K874908 | C900 X-Ray Film ProcessorIXW · Traditional | 02/12/1988SE |
| K874687 | Colli-Matetm Model No. B800IZX · Traditional | 12/30/1987SE |
| K851440 | Rdiographic Wall Holder or Film ReceptorIXY · Traditional | 06/05/1985SE |
| K850198 | Floor to Wall or Floor to Ceiling Tubestand;RadiogIYB · Traditional | 05/14/1985SE |
| K850118 | Xma Integrated TableIXQ · Traditional | 04/09/1985SE |
| K850117 | Xma 325 (X-Ray Generator)IZO · Traditional | 04/09/1985SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0468-2015 Class II | The J700 Floor Mounted Tube Stand (FMTS) is intended to support and position the…The welds on J700 tube stands may be insufficient resulting in tube stand breakage, damage to the X-Ray… | 10/28/2014Terminated |
| Z-1218-2007 | PCS125 Swivel Collimator, Model F100; Manual Radiographic Collimator; Summit Industries…The F100 Swivel Collimator may come loose from the tubestand and fall onto the x-ray table. | 08/10/2007Terminated |
| Z-1217-2007 | LX125V Swivel Collimator, Model E600; Manual Radiographic Collimator; Summit Industries…The E600 Swivel Collimator may come loose from the tubestand and fall onto the x-ray table. | 08/10/2007Terminated |
| Z-1216-2007 | LX125 Swivel Collimator, Model D800; Manual Radiographic Collimator; Summit Industries…The D800 Swivel Collimator may come loose from the tubestand and fall onto the x-ray table. | 08/10/2007Terminated |