The following data is part of a premarket notification filed by Biolucent, Inc. with the FDA for Mammopad Radiolucent Cushion.
| Device ID | K062141 |
| 510k Number | K062141 |
| Device Name: | MAMMOPAD RADIOLUCENT CUSHION |
| Classification | Camera, Scintillation (gamma) |
| Applicant | BIOLUCENT, INC. 6 JOURNEY, SUITE 325 Aliso Viejo, CA 92656 |
| Contact | Sheryl Higgins |
| Correspondent | Sheryl Higgins BIOLUCENT, INC. 6 JOURNEY, SUITE 325 Aliso Viejo, CA 92656 |
| Product Code | IYX |
| CFR Regulation Number | 892.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-27 |
| Decision Date | 2006-09-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 45420045505811 | K062141 | 000 |
| 45420045505804 | K062141 | 000 |
| 45420045505798 | K062141 | 000 |
| 45420045505781 | K062141 | 000 |
| 45420045505668 | K062141 | 000 |
| 25420045507347 | K062141 | 000 |
| 25420045507330 | K062141 | 000 |
| 25420045506951 | K062141 | 000 |
| 25420045506944 | K062141 | 000 |