The following data is part of a premarket notification filed by Norland Corp. with the FDA for Model Xct-900 Pqct X-ray Bone Densitometer.
| Device ID | K922286 |
| 510k Number | K922286 |
| Device Name: | MODEL XCT-900 PQCT X-RAY BONE DENSITOMETER |
| Classification | Densitometer, Bone |
| Applicant | NORLAND CORP. W6340 HACKBARTH RD. Fort Atkinson, WI 53538 |
| Contact | Terry Schwalenberg |
| Correspondent | Terry Schwalenberg NORLAND CORP. W6340 HACKBARTH RD. Fort Atkinson, WI 53538 |
| Product Code | KGI |
| CFR Regulation Number | 892.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-15 |
| Decision Date | 1992-11-27 |