Digital 625HF
FDA 510(k) K950291 · Fischer Imaging Corp.
510(k) numberK950291
Submission
- Device name
- Digital 625HF
- Applicant
- Fischer Imaging Corp.
Addison, IL, US - Received
- January 25, 1995
- Decision date
- March 23, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K952822 | Shimadzu X-Ray High Viltage Generator AHD150GIZO · Traditional | Shimadzu Corp. | 07/12/1995SE |
| K952265 | Milestonw 350/450/550HF, PCX N350/450/550HF, Top-X 350/450/550HF Radiographic X-Ray…IZO · Traditional | Control-X, Inc. | 07/06/1995SE |
| K950883 | Polydoros SX 65 and 80IZO · Traditional | Siemens Medical Solutions USA, Inc. | 04/03/1995SE |
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| 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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| K944150 | Micro X-65 HFIZO · Traditional | 09/16/1994SE |
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Questions and answers
When was Digital 625HF cleared by the FDA?
Digital 625HF (K950291) received a 510(k) decision of Substantially Equivalent on March 23, 1995, 57 days after the submission was received.
What is the product code of K950291?
The FDA product code is IZO – Generator, High-Voltage, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1700.