X-Ray, Portable
FDA 510(k) K781276 · Air-Shields, Inc.
510(k) numberK781276
Submission
- Device name
- X-Ray, Portable
- Applicant
- Air-Shields, Inc.
Mchenry, IL, US - Received
- July 24, 1978
- Decision date
- August 10, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K260236 | XliteIZL · Traditional | Gemss Healthcare Co., Ltd. | 08/03/2026SE |
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| K253185 | Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray SystemIZL · Traditional | Carestream Health | 03/11/2026SE |
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| K251710 | Mobile X-ray unit (!M1)IZL · Traditional | Solutions For Tomorrow AB | 10/24/2025SE |
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| K251223 | HnX-P1, HnX-PBIZL · Traditional | H&abyz Co., Ltd. | 08/04/2025SE |
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| K940975 | C450/C400 Infant IncubatorsFMZ · Traditional | 06/23/1994SE |
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Questions and answers
When was X-Ray, Portable cleared by the FDA?
X-Ray, Portable (K781276) received a 510(k) decision of Substantially Equivalent on August 10, 1978, 17 days after the submission was received.
What is the product code of K781276?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.