The following data is part of a premarket notification filed by Medical Systems, Inc. with the FDA for Xct 2000 L Pqct Bone Densitometer.
| Device ID | K983273 |
| 510k Number | K983273 |
| Device Name: | XCT 2000 L PQCT BONE DENSITOMETER |
| Classification | Densitometer, Bone |
| Applicant | MEDICAL SYSTEMS, INC. W6340 HACKBARTH RD. Fort Atkinson, WI 53538 |
| Contact | Terry Schwalenberg |
| Correspondent | Terry Schwalenberg MEDICAL SYSTEMS, INC. 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 | 1998-09-17 |
| Decision Date | 1998-10-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260491560025 | K983273 | 000 |
| 04260491560018 | K983273 | 000 |