Company ยท US
Summit Industries, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1985 to 2018. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
4recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 9, 2018 | K173823 | Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography System; Amrad Medical DFMT Digi Summit Industries, LLC | KPR |
| Mar 14, 2016 | K153119 | Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography SystemAmrad Medical FRS Digital Ra Summit Industries, LLC | KPR |
| Feb 12, 1988 | K874908 | C900 X-RAY FILM PROCESSOR Summit Industries, Inc. | IXW |
| Dec 30, 1987 | K874687 | COLLI-MATETM MODEL NO. B800 Summit Industries, Inc. | IZX |
| Jun 5, 1985 | K851440 | RDIOGRAPHIC WALL HOLDER OR FILM RECEPTOR Summit Industries, Inc. | IXY |
| May 14, 1985 | K850198 | FLOOR TO WALL OR FLOOR TO CEILING TUBESTAND;RADIOG Summit Industries, Inc. | IYB |
| Apr 9, 1985 | K850118 | XMA INTEGRATED TABLE Summit Industries, Inc. | IXQ |
| Apr 9, 1985 | K850117 | XMA 325 (X-RAY GENERATOR) Summit Industries, Inc. | IZO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 1, 2014 | Summit Industries Inc. The J700 Floor Mounted Tube Stand (FMTS) is intended to support and position the diagnostic x-ray tube housing assembly for a medical radiographic procedure. The product consists of a vertical column Terminated |
IYB | K850198 |
| Aug 29, 2007 | Summit Industries Inc. PCS125 Swivel Collimator, Model F100; Manual Radiographic Collimator; Summit Industries, Inc., Chicago, Illinois Terminated |
IZX | K874687 |
| Aug 29, 2007 | Summit Industries Inc. LX125V Swivel Collimator, Model E600; Manual Radiographic Collimator; Summit Industries, Inc., Chicago, Illinois Terminated |
IZX | K874687 |
| Aug 29, 2007 | Summit Industries Inc. LX125 Swivel Collimator, Model D800; Manual Radiographic Collimator; Summit Industries, Inc., Chicago, Illinois Terminated |
IZX | K874687 |