Company ยท US
Acoma Medical Imaging, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1989 to 1998. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| IYB | Tube Mount, X-Ray, Diagnostic | 2 |
| IZL | System, X-Ray, Mobile | 2 |
| OXO | Image-Intensified Fluoroscopic X-Ray System, Mobile | 2 |
| IXR | Table, Radiographic, Tilting | 1 |
| IZH | System, X-Ray, Mammographic | 1 |
| IZI | System, X-Ray, Angiographic | 1 |
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | 1 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 1 |
| KPR | System, X-Ray, Stationary | 1 |
| KPX | Changer, Radiographic Film/Cassette | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 30, 1998 | K981227 | SYMPHONY 360 REMOTE CONTROL TABLE Acoma Medical Imaging, Inc. | JAA |
| Jun 26, 1998 | K981131 | PATHFINDER MOBILE C ARM Acoma Medical Imaging, Inc. | OXO |
| Jan 23, 1997 | K963851 | TILTING RADIOGRAPHIC TABLE (REMOTE) Acoma Medical Imaging, Inc. | IXR |
| Feb 17, 1995 | K944952 | ANGIOGRAPHIC SYSTEM Acoma Medical Imaging, Inc. | IZI |
| Jul 29, 1994 | K941017 | F/C/W TUBESTAND Acoma Medical Imaging, Inc. | IYB |
| Jul 29, 1994 | K941004 | CTS SYSTEM Acoma Medical Imaging, Inc. | IYB |
| Feb 1, 1993 | K925598 | BUCKYMATIC AUTOMATIC CHEST FILM CHANGER Acoma Medical Imaging, Inc. | KPX |
| Oct 5, 1992 | K921116 | PX-100 PORTABLE X-RAY GENERATOR Acoma Medical Imaging, Inc. | IZL |
| Aug 27, 1992 | K921425 | SCD-105 AND SCD-125 CAPACITOR DISCHARGE MOBILE X-R Acoma Medical Imaging, Inc. | IZL |
| Aug 3, 1990 | K902637 | FUTURUS 2001 X-RAY GENERATOR Acoma Medical Imaging, Inc. | IZO |
| Apr 10, 1990 | K900562 | TRANS X 100 CHEST FILM CHANGER Acoma Medical Imaging, Inc. | KPR |
| Jul 14, 1989 | K893617 | MOBILE C-ARM Acoma Medical Imaging, Inc. | OXO |
| Mar 23, 1989 | K884345 | MODEL ESP-200 MAMMOGRAPHIC SYSTEM Acoma Medical Imaging, Inc. | IZH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||