Shimadzu Whole Body X-Ray CT Scanner SCT-3000TX
FDA 510(k) K875370 · Shimadzu Precision Instruments, Inc.
510(k) numberK875370
Submission
- Device name
- Shimadzu Whole Body X-Ray CT Scanner SCT-3000TX
- Applicant
- Shimadzu Precision Instruments, Inc.
Torrance, CA, US - Received
- December 31, 1987
- Decision date
- May 18, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K940294 | Shimadzu Mobile X-Ray SystemsOXO · Traditional | 03/16/1994SE |
| K890913 | Sdu 800 Diagnostic Ultrasound InstrumentIYO · Traditional | 09/06/1989SE |
| K884598 | Shimadzu Digital Subtraction System DAR-1200JAA · Traditional | 04/20/1989SE |
| K884477 | Shimadzu X-Ray High Voltage Generator UD150BKPR · Traditional | 03/15/1989SE |
| 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 |
| K881795 | Shimadzu X-Ray High Voltage Generator UD150KIZO · Traditional | 07/01/1988SE |
| K874910 | Shimadzu Digital Subtraction System DAR-200IZI · Traditional | 07/01/1988SE |
| K874946 | Shimadzu X-Ray High Voltage Generator HD150G-60IZO · Traditional | 03/03/1988SE |
Questions and answers
When was Shimadzu Whole Body X-Ray CT Scanner SCT-3000TX cleared by the FDA?
Shimadzu Whole Body X-Ray CT Scanner SCT-3000TX (K875370) received a 510(k) decision of Substantially Equivalent on May 18, 1988, 139 days after the submission was received.
What is the product code of K875370?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.