The following data is part of a premarket notification filed by Sun Nuclear Corp. with the FDA for 3d Scanner, Model 1230.
| Device ID | K101992 |
| 510k Number | K101992 |
| Device Name: | 3D SCANNER, MODEL 1230 |
| Classification | Accelerator, Linear, Medical |
| Applicant | SUN NUCLEAR CORP. 425-A PINEDA COURT Melbourne, FL 32940 |
| Contact | Noel Downey |
| Correspondent | Noel Downey SUN NUCLEAR CORP. 425-A PINEDA COURT Melbourne, FL 32940 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-15 |
| Decision Date | 2010-10-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B01612300004Z0 | K101992 | 000 |
| 05060608881130 | K101992 | 000 |
| 05060608880928 | K101992 | 000 |
| 05060608880324 | K101992 | 000 |
| 05060608880195 | K101992 | 000 |
| 05060608880201 | K101992 | 000 |
| 05060608880331 | K101992 | 000 |
| B01612300000TZ0 | K101992 | 000 |
| B01612300000Z0 | K101992 | 000 |
| B01612300002Z0 | K101992 | 000 |
| 05060608881123 | K101992 | 000 |