Summit Industries Inc.
FDA Regulatory Profile
Summit Industries Inc. appears in FDA public data with 1 recall, 8 510(k) clearances, 9 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0468-2015, Class II) was initiated on October 28, 2014. Its most recent 510(k) clearance was granted on February 9, 2018.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 8
- Inspections
- 9
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0468-2015 | Class II | The J700 Floor Mounted Tube Stand (FMTS) is intended to support and position the diagnostic x-ray tu | October 28, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K173823 | Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography System; Amr | February 9, 2018 |
| K153119 | Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography SystemAmrad Me | March 14, 2016 |
| K874908 | C900 X-RAY FILM PROCESSOR | February 12, 1988 |
| K874687 | COLLI-MATETM MODEL NO. B800 | December 30, 1987 |
| K851440 | RDIOGRAPHIC WALL HOLDER OR FILM RECEPTOR | June 5, 1985 |
| K850198 | FLOOR TO WALL OR FLOOR TO CEILING TUBESTAND;RADIOG | May 14, 1985 |
| K850118 | XMA INTEGRATED TABLE | April 9, 1985 |
| K850117 | XMA 325 (X-RAY GENERATOR) | April 9, 1985 |