APX-24 Portable X-ray System
FDA 510(k) K220678 · Aspenstate, Inc.
510(k) numberK220678
Submission
- Device name
- APX-24 Portable X-ray System
- Applicant
- Aspenstate, Inc.
Plano, TX, US - Received
- March 8, 2022
- Decision date
- March 31, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
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| 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 |
Questions and answers
When was APX-24 Portable X-ray System cleared by the FDA?
APX-24 Portable X-ray System (K220678) received a 510(k) decision of Substantially Equivalent on March 31, 2022, 23 days after the submission was received.
What is the product code of K220678?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.