FDA Registration
Active
🇺🇸 United States
SUMMIT INDUSTRIES, LLC
Reg #: 1450503
·
FEI: 1450503
·
Expires 2026
Products
8
Proprietary Names
32
Establishment Types
2
Classifications
8
Registration Details
- Registration Name
- SUMMIT INDUSTRIES, LLC
- Registration Number
- 1450503
- FEI Number
- 1450503
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 7555 N. Caldwell Avenue
- City
- Niles
- State
- IL
- ZIP
- 60714
- Country
- US
Regulatory Submissions
- 510(k) Number
- K173823
Owner / Operator
- Firm Name
- SUMMIT INDUSTRIES, LLC
- Operator Number
- 1450503
- Address
- 7555 N. Caldwell Avenue, --
- City
- Niles
- State
- IL
- Postal Code
- 60714
- Country
- US
- Correspondent
- Joe Flies
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Generator, High-Voltage, X-Ray, Diagnostic | IZO | Class 1 | Radiology | No | 2001-07-18 |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | Class 2 | Radiology | No | 2022-05-31 |
| System, X-Ray, Stationary | KPR | Class 2 | Radiology | No | 2022-05-31 |
| Tube Mount, X-Ray, Diagnostic | IYB | Class 1 | Radiology | No | 2001-11-26 |
| Holder, Radiographic Cassette, Wall-Mounted | IXY | Class 1 | Radiology | No | 2001-11-26 |
| Collimator, Manual, Radiographic | IZX | Class 2 | Radiology | No | 2008-02-01 |
| Table, Radiographic, Stationary Top | IXQ | Class 2 | Radiology | No | 2001-11-26 |
| Table, Radiographic, Non-Tilting, Powered | IZZ | Class 2 | Radiology | No | 2019-08-27 |
Proprietary Names
L550
L300
L500
03900
00210
03901
FMT System
DFMT System
S105
S203
S225
S113
J700
J309
S114
A-172F
S108
S109
S111
J1000
S107
S102
LX125
D800
C256
S204
S212
S200
S222
S211
S223
S210
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198