The following data is part of a premarket notification filed by Sun Nuclear Corp. with the FDA for Qed Diode Detectors, Models 1112-1116.
| Device ID | K011466 |
| 510k Number | K011466 |
| Device Name: | QED DIODE DETECTORS, MODELS 1112-1116 |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | SUN NUCLEAR CORP. 425-A PINEDA COURT Melbourne, FL 32940 |
| Contact | Jim Mixon |
| Correspondent | Jim Mixon SUN NUCLEAR CORP. 425-A PINEDA COURT Melbourne, FL 32940 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-14 |
| Decision Date | 2001-06-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B01611160006Z0 | K011466 | 000 |
| 05060608880393 | K011466 | 000 |
| 05060608880409 | K011466 | 000 |
| 05060608880423 | K011466 | 000 |
| 05060608880447 | K011466 | 000 |
| B01611120002Z0 | K011466 | 000 |
| B01611120003Z0 | K011466 | 000 |
| B01611120006Z0 | K011466 | 000 |
| B01611130002Z0 | K011466 | 000 |
| B01611130003Z0 | K011466 | 000 |
| B01611130006Z0 | K011466 | 000 |
| B01611140002Z0 | K011466 | 000 |
| B01611140003Z0 | K011466 | 000 |
| B01611150002Z0 | K011466 | 000 |
| B01611150003Z0 | K011466 | 000 |
| B01611150006Z0 | K011466 | 000 |
| B01611160002Z0 | K011466 | 000 |
| B01611160003Z0 | K011466 | 000 |
| 05060608880386 | K011466 | 000 |