The following data is part of a premarket notification filed by Lorad Medical Systems, Inc. with the FDA for Stereotactic Breast Lesion Localization Accessory.
| Device ID | K882875 |
| 510k Number | K882875 |
| Device Name: | STEREOTACTIC BREAST LESION LOCALIZATION ACCESSORY |
| Classification | System, X-ray, Mammographic |
| Applicant | LORAD MEDICAL SYSTEMS, INC. EAGLE ROAD, COMMERCE PARK Danbury, CT 06810 |
| Contact | Ed Mcdermott |
| Correspondent | Ed Mcdermott LORAD MEDICAL SYSTEMS, INC. EAGLE ROAD, COMMERCE PARK Danbury, CT 06810 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-11 |
| Decision Date | 1988-11-07 |