Acoma Medical Imaging, Inc.
Wheeling, IL, US
Acoma Medical Imaging, Inc. appears in FDA device records in Wheeling, IL. FDA records list 13 510(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
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for Acoma Medical Imaging, Inc. between 1989 and 1998. The busiest year on record is 1989, with 2. The most recent is 1998, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 2 |
| 1990 | 2 |
| 1992 | 2 |
| 1993 | 1 |
| 1994 | 2 |
| 1995 | 1 |
| 1997 | 1 |
| 1998 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K981227 | SYMPHONY 360 REMOTE CONTROL TABLE | JAA | Substantially Equivalent | |
| K981131 | PATHFINDER MOBILE C ARM | OXO | Substantially Equivalent | |
| K963851 | TILTING RADIOGRAPHIC TABLE (REMOTE) | IXR | Substantially Equivalent | |
| K944952 | ANGIOGRAPHIC SYSTEM | IZI | Substantially Equivalent | |
| K941017 | F/C/W TUBESTAND | IYB | Substantially Equivalent | |
| K941004 | CTS SYSTEM | IYB | Substantially Equivalent | |
| K925598 | BUCKYMATIC AUTOMATIC CHEST FILM CHANGER | KPX | Substantially Equivalent | |
| K921116 | PX-100 PORTABLE X-RAY GENERATOR | IZL | Substantially Equivalent | |
| K921425 | SCD-105 AND SCD-125 CAPACITOR DISCHARGE MOBILE X-R | IZL | Substantially Equivalent | |
| K902637 | FUTURUS 2001 X-RAY GENERATOR | IZO | Substantially Equivalent | |
| K900562 | TRANS X 100 CHEST FILM CHANGER | KPR | Substantially Equivalent | |
| K893617 | MOBILE C-ARM | OXO | Substantially Equivalent | |
| K884345 | MODEL ESP-200 MAMMOGRAPHIC SYSTEM | IZH | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KPXChanger, Radiographic Film/Cassette
- IZOGenerator, High-Voltage, X-Ray, Diagnostic
- OXOImage-Intensified Fluoroscopic X-Ray System, Mobile
- IZISystem, X-Ray, Angiographic
- JAASystem, X-Ray, Fluoroscopic, Image-Intensified
- IZHSystem, X-Ray, Mammographic
- IZLSystem, X-Ray, Mobile
- KPRSystem, X-Ray, Stationary
- IXRTable, Radiographic, Tilting
- IYBTube Mount, X-Ray, Diagnostic
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain