The following data is part of a premarket notification filed by Sun Nuclear Corp. with the FDA for Sun 125c Ionization Chamber.
| Device ID | K112981 |
| 510k Number | K112981 |
| Device Name: | SUN 125C IONIZATION CHAMBER |
| Classification | System, Radiation Therapy, Charged-particle, Medical |
| Applicant | SUN NUCLEAR CORP. 425 PINEDA COURT Melbourne, FL 32940 |
| Contact | Noel Downey |
| Correspondent | Noel Downey SUN NUCLEAR CORP. 425 PINEDA COURT Melbourne, FL 32940 |
| Product Code | LHN |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-06 |
| Decision Date | 2012-01-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B01610470001Z0 | K112981 | 000 |
| 05060608880249 | K112981 | 000 |
| 05060608880126 | K112981 | 000 |
| 05060608880119 | K112981 | 000 |
| 05060608880133 | K112981 | 000 |
| 05060608880225 | K112981 | 000 |
| B01610410000Z0 | K112981 | 000 |
| B01610410001Z0 | K112981 | 000 |
| B01610450000Z0 | K112981 | 000 |
| B01610450001Z0 | K112981 | 000 |
| B01610470000Z0 | K112981 | 000 |
| 05060608880232 | K112981 | 000 |