Shimadzu X-Ray High Voltage Generator UD150K
FDA 510(k) K881795 · Shimadzu Precision Instruments, Inc.
510(k) numberK881795
Submission
- Device name
- Shimadzu X-Ray High Voltage Generator UD150K
- Applicant
- Shimadzu Precision Instruments, Inc.
Torrance, CA, US - Received
- April 27, 1988
- Decision date
- July 1, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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 |
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| K950040 | Sii 525 AprIZO · Traditional | Scott Imaging Intl., Inc. | 03/21/1995SE |
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| K940294 | Shimadzu Mobile X-Ray SystemsOXO · Traditional | 03/16/1994SE |
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| K875378 | Single Photon Set 031 & AZ-701-NTS-SP EmissionKPS · Traditional | 11/16/1988SE |
| K882311 | Shimadzu Lateral C-Arm MH-31JAA · Traditional | 09/14/1988SE |
| K881674 | Shimadzu Whole Body X-Ray CT Scanner SCT-3000TCJAK · Traditional | 09/02/1988SE |
| K874910 | Shimadzu Digital Subtraction System DAR-200IZI · Traditional | 07/01/1988SE |
| K875370 | Shimadzu Whole Body X-Ray CT Scanner SCT-3000TXJAK · Traditional | 05/18/1988SE |
| K874946 | Shimadzu X-Ray High Voltage Generator HD150G-60IZO · Traditional | 03/03/1988SE |
Questions and answers
When was Shimadzu X-Ray High Voltage Generator UD150K cleared by the FDA?
Shimadzu X-Ray High Voltage Generator UD150K (K881795) received a 510(k) decision of Substantially Equivalent on July 1, 1988, 65 days after the submission was received.
What is the product code of K881795?
The FDA product code is IZO – Generator, High-Voltage, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1700.