FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SINGLE PHOTON SET 031 & AZ-701-NTS-SP EMISSION
K Number: K875378
·
Decision Nov 16, 1988
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
470
Applicant Total
23
Review Days
321
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Basic Information
- Device Name
- SINGLE PHOTON SET 031 & AZ-701-NTS-SP EMISSION
- K Number
- K875378
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1200
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Shimadzu Precision Instruments, Inc.
- Date Received
- December 31, 1987
- Decision Date
- November 16, 1988
- Product Code
- KPS
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KPS | System, Tomography, Computed, Emission | FDA class 2 | Radiology |
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Other Clearances by Shimadzu Precision Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K940294 | SHIMADZU MOBILE X-RAY SYSTEMS | Mar 16, 1994 | Substantially Equivalent |
| K890913 | SDU 800 DIAGNOSTIC ULTRASOUND INSTRUMENT | Sep 6, 1989 | Substantially Equivalent |
| K884598 | SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-1200 | Apr 20, 1989 | Substantially Equivalent |
| K884477 | SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150B | Mar 15, 1989 | Substantially Equivalent |
| K882311 | SHIMADZU LATERAL C-ARM MH-31 | Sep 14, 1988 | Substantially Equivalent |
| K881674 | SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TC | Sep 2, 1988 | Substantially Equivalent |
| K874910 | SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-200 | Jul 1, 1988 | Substantially Equivalent |
| K881795 | SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150K | Jul 1, 1988 | Substantially Equivalent |
| K875370 | SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TX | May 18, 1988 | Substantially Equivalent |
| K874946 | SHIMADZU X-RAY HIGH VOLTAGE GENERATOR HD150G-60 | Mar 3, 1988 | Substantially Equivalent |