Shimadzu Cerebral Angiographic Unit ER-100A
FDA 510(k) K875379 · Shimadzu Precision Instruments, Inc.
510(k) numberK875379
Submission
- Device name
- Shimadzu Cerebral Angiographic Unit ER-100A
- Applicant
- Shimadzu Precision Instruments, Inc.
Torrance, CA, US - Received
- December 31, 1987
- Decision date
- February 12, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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More from Surgvision GmbH
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K875370 | Shimadzu Whole Body X-Ray CT Scanner SCT-3000TXJAK · Traditional | 05/18/1988SE |
Questions and answers
When was Shimadzu Cerebral Angiographic Unit ER-100A cleared by the FDA?
Shimadzu Cerebral Angiographic Unit ER-100A (K875379) received a 510(k) decision of Substantially Equivalent on February 12, 1988, 43 days after the submission was received.
What is the product code of K875379?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.