ArcCHECK
Accelerator, Linear, Medical
SUN NUCLEAR CORPORATION
The following data is part of a premarket notification filed by Sun Nuclear Corporation with the FDA for Arccheck.
Pre-market Notification Details
| Device ID | K142617 |
| 510k Number | K142617 |
| Device Name: | ArcCHECK |
| Classification | Accelerator, Linear, Medical |
| Applicant | SUN NUCLEAR CORPORATION 3275 Suntree Blvd. Melbourne, FL 32940 |
| Contact | Noel Downey |
| Correspondent | James Luker James Luker 2640 NOBILITY AVE. Melbourne, FL 32934 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-16 |
| Decision Date | 2015-11-20 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B0161220200Z0 | K142617 | 000 |
Trademark Results [ArcCHECK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ARCCHECK 85497028 4213032 Live/Registered |
Sun Nuclear Corp. 2011-12-16 |
 ARCCHECK 85143089 4072822 Live/Registered |
Sun Nuclear Corp. 2010-10-01 |
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