Instrumentarium Imaging, Inc.
Milwaukee, WI, US
Instrumentarium Imaging, Inc. appears in FDA device records in Milwaukee, WI. FDA records list 24 510(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
- 24
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 24 510(k) clearances for Instrumentarium Imaging, Inc. between 1989 and 2000. The busiest year on record is 1990, with 5. The most recent is 2000, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 1 |
| 1990 | 5 |
| 1991 | 4 |
| 1992 | 4 |
| 1993 | 4 |
| 1996 | 1 |
| 1997 | 1 |
| 2000 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K002472 | DELTA 32 AND DELTA 32 TACT | IZH | Substantially Equivalent | |
| K001928 | SIGMA | MUH | Substantially Equivalent | |
| K000976 | DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM) | IZH | Substantially Equivalent | |
| K001171 | DELTA 16 TACT | IZH | Substantially Equivalent | |
| K973642 | ORTHOPANTOMOGRAPH OP100 AND ORTHOCEPH OC100 | EHD | Substantially Equivalent | |
| K955411 | DELTA 16 | IZH | Substantially Equivalent | |
| K925987 | INSTRUMENTARIUM MEGA4 HT | LNH | Substantially Equivalent | |
| K924921 | INSTRUMENTARIUM MEGA4 HT | LNH | Substantially Equivalent | |
| K924472 | INSTRUMENTARIUM MEGA4 HT | LNH | Substantially Equivalent | |
| K923581 | INSTRUMENTARIUM MEGA4 HT | LNH | Substantially Equivalent | |
| K923352 | INSTRUMENTARIUM MEGA4 HT | LNH | Substantially Equivalent | |
| K923022 | INSTRUMENTARIUM MEGA4 HT | LNH | Substantially Equivalent | |
| K920215 | INSTRUMENTARIUM MEGA4 HT | LNH | Substantially Equivalent | |
| K915552 | INSTRUMENTARIUM MEGA4 | LNH | Substantially Equivalent | |
| K912180 | MODEL MGB-301 DIAPHRAGM FILM 24 X 30 CM | IZX | Substantially Equivalent | |
| K912963 | INSTRUMENTARIUM MEGA4 | LNH | Substantially Equivalent | |
| K910111 | VARIOUS MODELS OF DAYLIGHT CASSETTE HOLDERS | IZH | Substantially Equivalent | |
| K896596 | ALPHA III PLUS AND MODEL P2500F/101 W/OPTIONAL | IZH | Substantially Equivalent | |
| K904528 | INSTRUMENTARIUM MEGA4, MODIFICATION | LNH | Substantially Equivalent | |
| K902044 | MEGA 4 MAGNETIC RESONANCE IMAGING SYSTEM | LNH | Substantially Equivalent | |
| K900967 | MODIFIED ALPHA MC-9R C-ARM | OXO | Substantially Equivalent | |
| K901620 | MULTIPURPOSE COIL & 3MM SLICE THICKNESS ON THE MRI | LNH | Substantially Equivalent | |
| K896309 | MAGNAVIEW M.R.I. VERSIONS 110FH & 110FM W/CARDIAC | LNH | Substantially Equivalent | |
| K891543 | MAGNAVIEW MOBILE MRI VERSION 110 FHM | LNH | 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