Recognized a 510(k)/PMA number — showing its clearance record and devices.
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Multi Hub Assembly | 01 | Noras MRI products GmbH | MOS | 04251269202339 |
| Grid Biopsy Unit: lateral for GE 8-Channel Breastc | 01 | Noras MRI products GmbH | MOS | 04251269202377 |
| Grid Needle Block reusable Encor 10G 4-hole | 01 | Noras MRI products GmbH | MOS | 04251269202124 |
| Breast Biopsy Set | 03 | Noras MRI products GmbH | MOS | 04251269203183 |
| Breast Biopsy Set Grid Reusable | 03 | Noras MRI products GmbH | MOS | 04251269203190 |
| Grid biopsy unit: medial, for GE 8-Channel breast | 01 | Noras MRI products GmbH | MOS | 04251269202384 |
| PP needle guide for SenoRX 7G | 03 | Noras MRI products GmbH | MOS | 04251269202261 |
| "P&P needle guide for ""Multi Hub Assembly""" | 01 | Noras MRI products GmbH | MOS | 04251269202322 |
| Grid Needle Block reusable Encor 10G 5-hole | 01 | Noras MRI products GmbH | MOS | 04251269202131 |
| PP needle guide for GE | 01 | Noras MRI products GmbH | MOS | 04251269202421 |
| P&P marker for Vacora | 03 | Noras MRI products GmbH | MOS | 04251269202186 |
| P&P needle guide for Vacora | 02 | Noras MRI products GmbH | MOS | 04251269202179 |
| PP positioning unit lateral for GE | 01 | Noras MRI products GmbH | MOS | 04251269202407 |
| PP needle guide for SenoRX 10G | 01 | Noras MRI products GmbH | MOS | 04251269202230 |
| Breast Biopsie Set Disposable | 02 | Noras MRI products GmbH | MOS | 04251269203206 |
| Grid Needle Block reusable Mammotome | 01 | Noras MRI products GmbH | MOS | 04251269202155 |
| PP positioning unit medial for GE | 01 | Noras MRI products GmbH | MOS | 04251269202414 |
| Slat plat horizontal - medial, cc | 01 | Noras MRI products GmbH | MOS | 04251269201769 |
| Grid biopsy unit for BBC | 01 | Noras MRI products GmbH | MOS | 04251269202445 |
| PP positioning unit for Mammotome for GE | 01 | Noras MRI products GmbH | MOS | 04251269202353 |
| Cranio-Caudal Fixation Unit CC-320-Plus | 03 | Noras MRI products GmbH | MOS | 04251269205316 |
| "MR compatible tweezers 4,5""" | 01 | Noras MRI products GmbH | MOS | 04251269202452 |
| Grid Needle Block reusable ATEC raw | 01 | Noras MRI products GmbH | MOS | 04251269202100 |
| Coaxial Highfield 12G 111mm 3T, unsteril | 01 | Noras MRI products GmbH | MOS | 04251269201813 |
| PP marker for SenoRX 7G | 04 | Noras MRI products GmbH | MOS | 04251269202278 |