SCD-105 and SCD-125 Capacitor Discharge Mobile X-R
FDA 510(k) K921425 · Acoma Medical Imaging, Inc.
510(k) numberK921425
Submission
- Device name
- SCD-105 and SCD-125 Capacitor Discharge Mobile X-R
- Applicant
- Acoma Medical Imaging, Inc.
Wheeling, IL, US - Received
- March 24, 1992
- Decision date
- August 27, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code IZL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260236 | XliteIZL · Traditional | Gemss Healthcare Co., Ltd. | 08/03/2026SE |
| K253058 | Portable DR Imaging SystemIZL · Traditional | Shantou Institute of Ultrasonic Instruments Co.… | 06/18/2026SE |
| K260085 | RAYMO Mobile X-ray System (Model: RAYMO)IZL · Traditional | DRGEM Corporation | 05/14/2026SE |
| K253185 | Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray SystemIZL · Traditional | Carestream Health | 03/11/2026SE |
| K253244 | AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)IZL · Traditional | Poskom Co., Ltd. | 02/23/2026SE |
| K250976 | Airbile-100IZL · Traditional | Poskom Co., Ltd. | 12/19/2025SE |
| K251710 | Mobile X-ray unit (!M1)IZL · Traditional | Solutions For Tomorrow AB | 10/24/2025SE |
| K243864 | BONX805IZL · Traditional | Bontech Co., Ltd. | 09/12/2025SE |
| K251443 | PromoIZL · Traditional | DRGEM Corporation | 08/22/2025SE |
| K251223 | HnX-P1, HnX-PBIZL · Traditional | H&abyz Co., Ltd. | 08/04/2025SE |
More from H&abyz Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K981227 | Symphony 360 Remote Control TableJAA · Traditional | 06/30/1998SE |
| K981131 | Pathfinder Mobile C ArmOXO · Abbreviated | 06/26/1998SE |
| 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 |
| K902637 | Futurus 2001 X-Ray GeneratorIZO · Traditional | 08/03/1990SE |
| K900562 | Trans X 100 Chest Film ChangerKPR · Traditional | 04/10/1990SE |
Questions and answers
When was SCD-105 and SCD-125 Capacitor Discharge Mobile X-R cleared by the FDA?
SCD-105 and SCD-125 Capacitor Discharge Mobile X-R (K921425) received a 510(k) decision of Substantially Equivalent on August 27, 1992, 156 days after the submission was received.
What is the product code of K921425?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.