ECT (EMMISSION COMPUTED TOMOGRAPHY) CARBON FIB PAL
FDA 510(k) clearance K903767 · decided 1990-09-07
Clearance details
- K-number
- K903767
- Device name
- ECT (EMMISSION COMPUTED TOMOGRAPHY) CARBON FIB PAL
- Applicant
- Siemens Gammasonics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-08-20
- Decision date
- 1990-09-07
- Days to decision
- 18 days
- Clearance type
- Traditional
- Product code
- IYZ
- Device class
- 1
- Regulation number
- 892.1350
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Hoffman Estates, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MULTIPLE ACCESSORY TO GAMMA CAMERAS (K920962) | Nu Age Products | 1992-04-17 |
| SPECT TABLE, MODEL #056-760 (K915541) | Atomic Products Corp. | 1992-01-17 |
| XYZ CRANK IMAGING TABLE (K911691) | Med-Tron Products, Inc. | 1991-08-09 |
| ECT CARBON FIBER PALLET, MODIFICATION (K912481) | Siemens Gammasonics, Inc. | 1991-08-02 |
| CARDIAC SPECT PALLET (K912286) | Siemens Gammasonics, Inc. | 1991-08-02 |
| E-Z LIFT CRANK IMAGING TABLE (K912181) | Med-Tron Products, Inc. | 1991-07-17 |
| XY IMAGING TABLE (K912135) | Med-Tron Products, Inc. | 1991-07-17 |
| E-Z LIFT IMAGING TABLE WITH FOOT PUMP (K911564) | Med-Tron Products, Inc. | 1991-07-15 |
| XYZ IMAGING TABLE WITH FOOT PUMP (K911561) | Med-Tron Products, Inc. | 1991-07-15 |
| SCANNING COT (K903901) | Med-Tron Products, Inc. | 1990-09-21 |
| QRSYSTEMS H.D. NUCLEAR IMAGING TABLE (K893826) | Qrsystems, Inc. | 1989-08-02 |
Recalls involving this device
No recalls on record reference this clearance.