Trans X 100 Chest Film Changer
FDA 510(k) K900562 · Acoma Medical Imaging, Inc.
510(k) numberK900562
Submission
- Device name
- Trans X 100 Chest Film Changer
- Applicant
- Acoma Medical Imaging, Inc.
Wheeling, IL, US - Received
- February 7, 1990
- Decision date
- April 10, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K260227 | EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS…KPR · Traditional | DRTECH Corporation | 09/08/2026SE |
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| K260481 | GC85AKPR · Traditional | Samsung Electronics Co., Ltd. | 08/27/2026SE |
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| K253446 | AeroDR TX c02KPR · Traditional | Dk Medical Systems Co., Ltd. | 04/10/2026SE |
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| K252000 | uDR Arria & uDR ArisKPR · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 11/26/2025SE |
| K251167 | uDR Aurora CXKPR · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 09/19/2025SE |
| K250788 | Definium Tempo SelectKPR · Traditional | Ge Hualun Medical Systems Co. , Ltd. | 08/28/2025SE |
| K250790 | Innovision-DxiiKPR · Traditional | Dk Medical Systems Co., Ltd. | 08/01/2025SE |
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| K981227 | Symphony 360 Remote Control TableJAA · Traditional | 06/30/1998SE |
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| K963851 | Tilting Radiographic Table (Remote)IXR · Traditional | 01/23/1997SE |
| K944952 | Angiographic SystemIZI · Traditional | 02/17/1995SE |
| K941017 | F/C/W TubestandIYB · Traditional | 07/29/1994SE |
| K941004 | CTS SystemIYB · Traditional | 07/29/1994SE |
| K925598 | Buckymatic Automatic Chest Film ChangerKPX · Traditional | 02/01/1993SE |
| K921116 | PX-100 Portable X-Ray GeneratorIZL · Traditional | 10/05/1992SE |
| K921425 | SCD-105 and SCD-125 Capacitor Discharge Mobile X-RIZL · Traditional | 08/27/1992SE |
| K902637 | Futurus 2001 X-Ray GeneratorIZO · Traditional | 08/03/1990SE |
Questions and answers
When was Trans X 100 Chest Film Changer cleared by the FDA?
Trans X 100 Chest Film Changer (K900562) received a 510(k) decision of Substantially Equivalent on April 10, 1990, 62 days after the submission was received.
What is the product code of K900562?
The FDA product code is KPR – System, X-Ray, Stationary, a Class II (moderate risk) device regulated under 21 CFR 892.1680.