Acu-Ray
FDA 510(k) K931279 · Sterne Equipment Co., Ltd.
510(k) numberK931279
Submission
- Device name
- Acu-Ray
- Applicant
- Sterne Equipment Co., Ltd.
Brampton, On., CA - Received
- March 8, 1993
- Decision date
- November 3, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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|---|---|---|---|
| K260236 | XliteIZL · Traditional | Gemss Healthcare Co., Ltd. | 08/03/2026SE |
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| 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 |
|---|---|---|
| K003433 | Neuro-Train III (3)IPF · Traditional | 06/15/2001SE |
| K980158 | Myo-Train V (5)IPF · Traditional | 07/28/1998SE |
| K972204 | Acu-Ray HF Series Portable X-Ray UnitIZL · Traditional | 10/08/1997SE |
| K970155 | Neuro-Train II (2)IPF · Traditional | 03/17/1997SE |
| K883896 | NeurotrainLIH · Traditional | 07/14/1989SE |
Questions and answers
When was Acu-Ray cleared by the FDA?
Acu-Ray (K931279) received a 510(k) decision of Substantially Equivalent on November 3, 1993, 240 days after the submission was received.
What is the product code of K931279?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.