AcuityPDR
FDA 510(k) K200726 · Radmedix, LLC
510(k) numberK200726
Submission
- Device name
- AcuityPDR
- Applicant
- Radmedix, LLC
Dayton, OH, US - Received
- March 20, 2020
- Decision date
- April 13, 2020
- 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 |
| 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 |
|---|---|---|
| K231995 | AcuityUDRKPR · Abbreviated | 10/25/2023SE |
| K231709 | AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4MQB · Traditional | 07/12/2023SE |
| K210919 | AcuityDReMQB · Traditional | 04/30/2021SE |
| K201058 | Accuvue+MQB · Special | 05/06/2020SE |
| K193360 | Acuity SDR Standard, Acuity SDR Plus, Acuity FDR StandardKPR · Traditional | 01/02/2020SE |
Questions and answers
When was AcuityPDR cleared by the FDA?
AcuityPDR (K200726) received a 510(k) decision of Substantially Equivalent on April 13, 2020, 24 days after the submission was received.
What is the product code of K200726?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.