Data / Medical devices / United States / Summit Industries, LLC
Summit Industries, LLC: FDA-registered device maker in Niles, IL, United States, 3 510(k) clearances
Summit Industries, LLC is registered with the FDA (registration 1450503) in Niles, IL, United States. It lists 8 device types. The FDA files 3 510(k) clearances under its listings, the newest dated February 9, 2018. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1450503
- Address
- 7555 N. Caldwell Avenue, Niles, IL, United States, 60714
- Owner or operator
- SUMMIT INDUSTRIES, LLC (1450503)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- July 18, 2001
- Registered through
- 2026
- Brand names listed
- 00210, 03900, 03901, A-172F, C256, D800, DFMT System, FMT System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Collimator, Manual, Radiographic | IZX | 2 | Complaint file establishment | accessdata.fda.gov |
| Generator, High-Voltage, X-Ray, Diagnostic | IZO | 1 | Manufacturer | accessdata.fda.gov |
| Holder, Radiographic Cassette, Wall-Mounted | IXY | 1 | Manufacturer | accessdata.fda.gov |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Stationary | KPR | 2 | Manufacturer | accessdata.fda.gov |
| Table, Radiographic, Non-Tilting, Powered | IZZ | 2 | Manufacturer | accessdata.fda.gov |
| Table, Radiographic, Stationary Top | IXQ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Tube Mount, X-Ray, Diagnostic | IYB | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 9, 2018 | 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 | Summit Industries, LLC | accessdata.fda.gov |
| March 14, 2016 | K153119 | Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography SystemAmrad Medical FRS Digital Radiography System, | KPR | Substantially Equivalent | Summit Industries, LLC | accessdata.fda.gov |
| December 30, 1987 | K874687 | COLLI-MATETM MODEL NO. B800 | IZX | Substantially Equivalent | Summit Industries, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 28, 2014 | 69631 | Class II | Terminated | 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 counterbalance | 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. | accessdata.fda.gov |
| August 10, 2007 | 38512 | Not yet classified | Terminated | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Holder, Radiographic Cassette, Wall-Mounted
- All makers of Generator, High-Voltage, X-Ray, Diagnostic
- All makers of Tube Mount, X-Ray, Diagnostic
- All makers of System, X-Ray, Stationary
- All makers of Solid State X-Ray Imager (Flat Panel/Digital Imager)
- All makers of Table, Radiographic, Non-Tilting, Powered
Updated February 9, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.