Mci Optonix
Sedona, AZ, US
MCI OPTONIX appears in FDA device records in Sedona, AZ. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Mci Optonix between 1990 and 1995. The busiest year on record is 1994, with 2. The most recent is 1995, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 1 |
| 1994 | 2 |
| 1995 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K953444 | MCI OPTONIX ECONOMY CASSETTE | IXA | Substantially Equivalent | |
| K945039 | MCI OPTONIX CASSETTE OKAMOTO CASSETE | IXA | Substantially Equivalent | |
| K941023 | RAREX GREEN FAST | EAM | Substantially Equivalent | |
| K902039 | RAREX & OPTEX X-RAY SCREENS | EAM | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2244584 | 2244584 | MCI OPTONIX | 2020 Contractors Rd Ste 8, Sedona, AZ 86336 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
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