Philips XRG 90 X-Ray Generator System
FDA 510(k) K933650 · Philips Medical Systems North America, Inc.
510(k) numberK933650
Submission
- Device name
- Philips XRG 90 X-Ray Generator System
- Applicant
- Philips Medical Systems North America, Inc.
Shelton, CT, US - Received
- July 27, 1993
- Decision date
- October 7, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K950291 | Digital 625HFIZO · Traditional | Fischer Imaging Corp. | 03/23/1995SE |
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| K950040 | Sii 525 AprIZO · Traditional | Scott Imaging Intl., Inc. | 03/21/1995SE |
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Questions and answers
When was Philips XRG 90 X-Ray Generator System cleared by the FDA?
Philips XRG 90 X-Ray Generator System (K933650) received a 510(k) decision of Substantially Equivalent on October 7, 1993, 72 days after the submission was received.
What is the product code of K933650?
The FDA product code is IZO – Generator, High-Voltage, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1700.