Norland Corp.
Mchenry, IL, US
Norland Corp. appears in FDA device records in Mchenry, IL. FDA records list 15 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 15
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 15 510(k) clearances for Norland Corp. between 1979 and 1998. The busiest year on record is 1998, with 5. The most recent is 1998, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 1 |
| 1984 | 1 |
| 1989 | 1 |
| 1990 | 1 |
| 1991 | 2 |
| 1992 | 1 |
| 1994 | 1 |
| 1995 | 1 |
| 1997 | 1 |
| 1998 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K980569 | FRACTURE RISK ASSESSMENT CAPABILITY FOR NORLAND X-RAY BONE DENSITOMETERS | KGI | Substantially Equivalent | |
| K980289 | FRACTURE RISK ASSESSMENT FOR THE NORLAND SXA 3000 BONE DENSITOMETER | KGI | Substantially Equivalent | |
| K980125 | REFERENCE POPULATION FOR NORLAND APOLLO X-RAY BONE DENSITOMETER | KGI | Substantially Equivalent | |
| K973459 | NORLAND BODY COMPOSITION OPTION FOR NORLAND DEXA BONE DENSITOMETERS | KGI | Substantially Equivalent | |
| K973104 | NORLAND MODEL PDEXA BONE DENSITOMETER | KGI | Substantially Equivalent | |
| K972882 | APOLLO | KGI | Substantially Equivalent | |
| K931996 | MODEL PDEXA BONE DENSITOMETER | KGI | Substantially Equivalent | |
| K926019 | FORARM OPT/NORLAND XR SERIES X-RAY BONE DENSITOMET | KGI | Substantially Equivalent | |
| K922286 | MODEL XCT-900 PQCT X-RAY BONE DENSITOMETER | KGI | Substantially Equivalent | |
| K913078 | LATERAL SPINE OPT. XR-SERIES X-RAY BONE DENSITOMET | KGI | Substantially Equivalent | |
| K901804 | NORLAND XR26 WHOLE BODY OPTION | KGI | Substantially Equivalent | |
| K902959 | NORLAND XR26 LATERAL SPINE OPTION | KGI | Substantially Equivalent | |
| K881865 | NORLAND MODEL XR-26 X-RAY BONE DENSITOMETER | KGI | Substantially Equivalent | |
| K841463 | BONE DENSITOMETER | KGI | Substantially Equivalent | |
| K792444 | NORLAND MODEL 278 BONE DENSITOMETER | KGI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain