The following data is part of a premarket notification filed by Usa Instruments, Inc. with the FDA for 3t Hd Breast Array.
| Device ID | K052585 |
| 510k Number | K052585 |
| Device Name: | 3T HD BREAST ARRAY |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | USA INSTRUMENTS, INC. 1515 DANNER DR. Aurora, OH 44202 |
| Contact | David Brown |
| Correspondent | David Brown USA INSTRUMENTS, INC. 1515 DANNER DR. Aurora, OH 44202 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-20 |
| Decision Date | 2005-10-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682103763 | K052585 | 000 |
| 00840682103756 | K052585 | 000 |