The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Gadolinium-153 Bone Densitometer (gdc.10411/10412).
| Device ID | K901854 |
| 510k Number | K901854 |
| Device Name: | GADOLINIUM-153 BONE DENSITOMETER (GDC.10411/10412) |
| Classification | Densitometer, Bone |
| Applicant | AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
| Contact | B Patterson |
| Correspondent | B Patterson AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
| Product Code | KGI |
| CFR Regulation Number | 892.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-24 |
| Decision Date | 1990-07-09 |