FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRIAD NUCLEAR IMAGING SYSTEM
K Number: K873775
·
Decision Jan 19, 1988
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
470
Applicant Total
16
Review Days
125
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Basic Information
- Device Name
- TRIAD NUCLEAR IMAGING SYSTEM
- K Number
- K873775
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1200
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Trionix Research Laboratory, Inc.
- Date Received
- September 16, 1987
- Decision Date
- January 19, 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 Trionix Research Laboratory, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K964438 | 511 KEV COLLIMATOR | May 29, 1997 | Substantially Equivalent |
| K962481 | QUASAR RECOVERY IMAGING PACKAGE | Nov 27, 1996 | Substantially Equivalent |
| K964265 | CARDIAC TRIAD NUCLEAR IMAGING SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY SYSTEM | Nov 12, 1996 | Substantially Equivalent |
| K964267 | MONAD NUCLEAR IMAGING SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY SYSTEM | Nov 12, 1996 | Substantially Equivalent |
| K964268 | TRIAD 88 NUCLEAR IMAGING SYSTEM | Nov 12, 1996 | Substantially Equivalent |
| K964266 | BIAD NUCLEAR IMAGING SYSTEM | Nov 12, 1996 | Substantially Equivalent |
| K961597 | GATED MIBI 3-D EJECTION FRACTION PROCESSING | Sep 4, 1996 | Substantially Equivalent |
| K923151 | CARDIAC TRIAD NEW DETECTOR OPTION | Sep 10, 1992 | Substantially Equivalent |
| K923345 | BIAD NEW DETECTOR OPTION | Sep 10, 1992 | Substantially Equivalent |
| K923044 | MONAD NUCLEAR IMAGING SYSTEM | Aug 27, 1992 | Substantially Equivalent |