510(k) K903767
- Device
- ECT (EMMISSION COMPUTED TOMOGRAPHY) CARBON FIB PAL
- Applicant
- SIEMENS GAMMASONICS, INC.
- 510(k) number
- K903767
- Product code
- IYZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-09-07
- Date received
- 1990-08-20
- Regulation
- 892.1350
- Classification name
- Bed, Scanning, Nuclear
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DENNIS W HENKELMAN
- Address
- 2501 N. Barrington Rd. Hoffman Estates IL US 60195 60195
FDA Registration Numbers#
- 9613299
- 9613445
- 3027338963
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IYZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K920962 | MULTIPLE ACCESSORY TO GAMMA CAMERAS | Nu Age Products | 1992-04-17 |
| K915541 | SPECT TABLE, MODEL #056-760 | Atomic Products Corp. | 1992-01-17 |
| K911691 | XYZ CRANK IMAGING TABLE | Med-Tron Products, Inc. | 1991-08-09 |
| K912286 | CARDIAC SPECT PALLET | Siemens Gammasonics, Inc. | 1991-08-02 |
| K912481 | ECT CARBON FIBER PALLET, MODIFICATION | Siemens Gammasonics, Inc. | 1991-08-02 |
| K912135 | XY IMAGING TABLE | Med-Tron Products, Inc. | 1991-07-17 |
| K912181 | E-Z LIFT CRANK IMAGING TABLE | Med-Tron Products, Inc. | 1991-07-17 |
| K911561 | XYZ IMAGING TABLE WITH FOOT PUMP | Med-Tron Products, Inc. | 1991-07-15 |
| K911564 | E-Z LIFT IMAGING TABLE WITH FOOT PUMP | Med-Tron Products, Inc. | 1991-07-15 |
| K903901 | SCANNING COT | Med-Tron Products, Inc. | 1990-09-21 |
| K893826 | QRSYSTEMS H.D. NUCLEAR IMAGING TABLE | Qrsystems, Inc. | 1989-08-02 |
Legacy Summary#
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FDA Review#
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