Himobilix 2N
FDA 510(k) K883161 · Bay X-Ray, Inc.
510(k) numberK883161
Submission
- Device name
- Himobilix 2N
- Applicant
- Bay X-Ray, Inc.
Walnut Creek, CA, US - Received
- July 26, 1988
- Decision date
- October 21, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K242488 | Soteria E-ViewJAA · Traditional | Omega Medical Imaging, LLC | 01/06/2025SE |
| K242948 | Adora DRFi (04550010)JAA · Traditional | Nrt X-Ray A/S | 12/23/2024SE |
| K233380 | TRIDENT Mobile Fluoroscopy SystemJAA · Traditional | Dornier Medtech America | 06/26/2024SE |
| K233945 | ProxiDiagnost N90 / Precision CRF (706110, 706400)JAA · Special | Philips Medical Systems Dmc GmbH | 01/11/2024SE |
| K232910 | CombiDiagnost R90JAA · Special | Philips Medical Systems Dmc GmbH | 10/19/2023SE |
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| K220871 | NautilusJAA · Special | Dornier Medtech America, Inc. | 04/18/2022SE |
| K212890 | Nyquist.IQJAA · Traditional | Omega Medical Imaging, LLC | 12/13/2021SE |
More from Omega Medical Imaging, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K883160 | Catapult Bucky (Katapult Blenda)KPR · Traditional | 09/08/1988SE |
| K883162 | Telestatix X-Ray TableIXR · Traditional | 09/06/1988SE |
| K883155 | Rastix X-Ray TableKXJ · Traditional | 09/06/1988SE |
| K883154 | Seldix 325 Two Pulse Generator/ControlIZO · Traditional | 09/06/1988SE |
| K883153 | Undistat with Explorator 35 (Ucs 35E)IXR · Traditional | 09/06/1988SE |
Questions and answers
When was Himobilix 2N cleared by the FDA?
Himobilix 2N (K883161) received a 510(k) decision of Substantially Equivalent on October 21, 1988, 87 days after the submission was received.
What is the product code of K883161?
The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.