Shimadzu X-Ray High Viltage Generator AHD150G
FDA 510(k) K952822 · Shimadzu Corp.
510(k) numberK952822
Submission
- Device name
- Shimadzu X-Ray High Viltage Generator AHD150G
- Applicant
- Shimadzu Corp.
Kyoto City 604 Japan, JP - Received
- June 20, 1995
- Decision date
- July 12, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K950883 | Polydoros SX 65 and 80IZO · Traditional | Siemens Medical Solutions USA, Inc. | 04/03/1995SE |
| K950694 | Compact-XIZO · Traditional | Electromed Intl., Ltd. | 03/31/1995SE |
| 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 |
| K945453 | Ud 150L-R IIIZO · Traditional | Shimadzu Medical Systems | 03/21/1995SE |
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Questions and answers
When was Shimadzu X-Ray High Viltage Generator AHD150G cleared by the FDA?
Shimadzu X-Ray High Viltage Generator AHD150G (K952822) received a 510(k) decision of Substantially Equivalent on July 12, 1995, 22 days after the submission was received.
What is the product code of K952822?
The FDA product code is IZO – Generator, High-Voltage, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1700.