X-Ray Generating System TF 1000
FDA 510(k) K881386 · General Medical Merate S.P.A
510(k) numberK881386
Submission
- Device name
- X-Ray Generating System TF 1000
- Applicant
- General Medical Merate S.P.A
Long Island City, NY, US - Received
- April 1, 1988
- Decision date
- July 8, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K954666 | MPH50, MPH65, and MPH80IZO · Traditional | GE Medical Systems | 11/24/1995SE |
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| K950883 | Polydoros SX 65 and 80IZO · Traditional | Siemens Medical Solutions USA, Inc. | 04/03/1995SE |
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| K950291 | Digital 625HFIZO · Traditional | Fischer Imaging Corp. | 03/23/1995SE |
| K950041 | Sii 360 AprIZO · Traditional | Scott Imaging Intl., Inc. | 03/21/1995SE |
| K950040 | Sii 525 AprIZO · Traditional | Scott Imaging Intl., Inc. | 03/21/1995SE |
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Questions and answers
When was X-Ray Generating System TF 1000 cleared by the FDA?
X-Ray Generating System TF 1000 (K881386) received a 510(k) decision of Substantially Equivalent on July 8, 1988, 98 days after the submission was received.
What is the product code of K881386?
The FDA product code is IZO – Generator, High-Voltage, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1700.