FDA Registration
Active
🇺🇸 United States
RAY AMERICA INC
Reg #: 3011471624
·
FEI: 3011471624
·
Expires 2026
Products
11
Proprietary Names
35
Establishment Types
1
Classifications
11
Research this establishment in seconds
The Research Assistant profiles FDA-registered establishments — listings, owners, related facilities — and cites every record.
Free to try · every answer cites its records
Registration Details
- Registration Name
- RAY AMERICA INC
- Registration Number
- 3011471624
- FEI Number
- 3011471624
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 400 Kelby Street, Ste. 1500
- City
- Fort Lee
- State
- NJ
- ZIP
- 07024
- Country
- US
Regulatory Submissions
- 510(k) Number
- K160788
Owner / Operator
- Firm Name
- RAY AMERICA INC
- Operator Number
- 10048938
- Address
- 400 Kelby Street, Ste. 1500
- City
- Fort Lee
- State
- NJ
- Postal Code
- 07024
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, X-Ray, Extraoral Source, Digital | MUH | Class 2 | Dental | No | 2016-09-21 |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | Class 2 | Dental | No | 2022-08-17 |
| X-Ray, Tomography, Computed, Dental | OAS | Class 2 | Radiology | No | 2025-12-15 |
| Teeth, Artificial, Posterior With Metal Insert | ELJ | Class 1 | Dental | No | 2017-07-12 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2019-01-03 |
| Material, Impression Tray, Resin | EBH | Class 1 | Dental | No | 2017-07-12 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2025-12-15 |
| Unit, X-Ray, Intraoral | EAP | Class 2 | Dental | No | 2023-11-21 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2017-07-12 |
| Orthodontic Software | PNN | Class 2 | Dental | No | 2024-07-15 |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | Class 2 | Radiology | No | 2015-03-23 |
Proprietary Names
RIOSCAN
RAYiOS2
RAYiOS
RCT700
VISION 16
RAYSCAN ALPHA PLUS
RAYDENT C&B
RAYSCAN a+
RCT800
RAYSCAN STUDIO
RAYQUANTUM
RCT600 Computed Tomography X-ray System
RIT-MU
RIT-LL
RIT-SU
RIT-LU
RIT-ML
RIT-PB
RIT-SL
RIT-PA
RAYDENT DM
Cocoon Portable Handheld X-Ray System
RAYSCAN ?-Expert
RAYSCAN A+
RAYSCAN A+ Vision 16
RAYSCAN S
RAYSCAN S Vision 20
VISION 20
VISION 18
RAYPreMiere
RAYSCAN ?-Expert 3D
SMARTDent
RIOSensor+ Intraoral X-ray unit
RAYDENT SG
RAYDENT SW
Establishment Types
Complaint File Establishment per 21 CFR 820.198