The following data is part of a premarket notification filed by Thomson-cgr Medical Corp. with the FDA for Stereotix.
| Device ID | K873618 |
| 510k Number | K873618 |
| Device Name: | STEREOTIX |
| Classification | System, X-ray, Mammographic |
| Applicant | THOMSON-CGR MEDICAL CORP. 10150 OLD COLUMBIA RD. Columbia, MD 21046 |
| Contact | Mary-jo Lyons |
| Correspondent | Mary-jo Lyons THOMSON-CGR MEDICAL CORP. 10150 OLD COLUMBIA RD. Columbia, MD 21046 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-08 |
| Decision Date | 1987-11-16 |