Summit Industries, LLC
Niles, IL, US
SUMMIT INDUSTRIES, LLC appears in FDA device records in Niles, IL. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Summit Industries, LLC between 1985 and 2018. The busiest year on record is 1985, with 4. The most recent is 2018, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 4 |
| 1987 | 1 |
| 1988 | 1 |
| 2016 | 1 |
| 2018 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K173823 | Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography System; Amrad Medical DFMT Digital Radiography System; Amrad Medical FMT Digital Radiography System | KPR | Substantially Equivalent | |
| K153119 | Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography SystemAmrad Medical FRS Digital Radiography System, | KPR | Substantially Equivalent | |
| K874908 | C900 X-RAY FILM PROCESSOR | IXW | Substantially Equivalent | |
| K874687 | COLLI-MATETM MODEL NO. B800 | IZX | Substantially Equivalent | |
| K851440 | RDIOGRAPHIC WALL HOLDER OR FILM RECEPTOR | IXY | Substantially Equivalent | |
| K850198 | FLOOR TO WALL OR FLOOR TO CEILING TUBESTAND;RADIOG | IYB | Substantially Equivalent | |
| K850118 | XMA INTEGRATED TABLE | IXQ | Substantially Equivalent | |
| K850117 | XMA 325 (X-RAY GENERATOR) | IZO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1450503 | 1450503 | SUMMIT INDUSTRIES, LLC | 7555 N. Caldwell Avenue, Niles, IL 60714 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- IZXCollimator, Manual, Radiographic
- IZOGenerator, High-Voltage, X-Ray, Diagnostic
- IXYHolder, Radiographic Cassette, Wall-Mounted
- IXWProcessor, Radiographic-Film, Automatic
- MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)
- KPRSystem, X-Ray, Stationary
- IZZTable, Radiographic, Non-Tilting, Powered
- IXQTable, Radiographic, Stationary Top
- IYBTube Mount, X-Ray, Diagnostic
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0468-2015 | 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 (with counterbalanced vertical carriage, counterweight and pulley system), horizontal floor car and a floor mounted track to ride on. | The welds on J700 tube stands may be insufficient resulting in tube stand breakage, damage to the X-Ray machine, and/or patient or healthcare provider injury. | Class II | Terminated | |
| Z-1218-2007 | PCS125 Swivel Collimator, Model F100; Manual Radiographic Collimator; Summit Industries, Inc., Chicago, Illinois | The F100 Swivel Collimator may come loose from the tubestand and fall onto the x-ray table. | Terminated | ||
| Z-1217-2007 | LX125V Swivel Collimator, Model E600; Manual Radiographic Collimator; Summit Industries, Inc., Chicago, Illinois | The E600 Swivel Collimator may come loose from the tubestand and fall onto the x-ray table. | Terminated | ||
| Z-1216-2007 | LX125 Swivel Collimator, Model D800; Manual Radiographic Collimator; Summit Industries, Inc., Chicago, Illinois | The D800 Swivel Collimator may come loose from the tubestand and fall onto the x-ray table. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain