510(k) K904599
- Device
- D2 SPECTRUM GAMMA CAMERA/CRYSTAL V COMPUTER SYSTEM
- Applicant
- DIGITAL DESIGN, INC.
- 510(k) number
- K904599
- Product code
- JWM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-04-23
- Date received
- 1990-10-10
- Regulation
- 892.1310
- Classification name
- System, Tomographic, Nuclear
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- THOMAS BERGQUIST
- Address
- 3060 E. Business Park Dr. Norcross GA US 30071 30071
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JWM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K914350 | ICON COMPUTER SYSTEM | Siemens Gammasonics, Inc. | 1991-11-22 |
| K903315 | ICON | Siemens Gammasonics, Inc. | 1991-01-09 |
| K901545 | GCA-9300 NUCLEAR TOMOGRAPHY SYSTEM | Toshiba America Medical Systems, In.C | 1990-06-26 |
| K874473 | ADAC MODEL ARC-ST, PC STYLE DATA PROCESSING SYSTEM | Adac Laboratories | 1988-07-18 |
| K873075 | ADAC MODEL ARC-5000, GAMMA CAMERA | Adac Laboratories | 1987-10-30 |
| K851685 | DIGITAL GAMMA CAMERA GCA 601 E | Toshiba Medical Systems | 1985-06-14 |
| K850885 | STARCAM DATA ACQUISITION & PROCESSING SYS H3300C | General Electric Co. | 1985-06-06 |
| K851686 | DIGITAL GAMMA CAMERA GCA 501S | Toshiba Medical Systems | 1985-06-05 |
| K851687 | JUMBO DIGITAL GAMMACAMERA GCA-90B | Toshiba Medical Systems | 1985-06-05 |
| K841905 | DOT-A, DOT-AR PXP-E, PXP-ER | Siemens Gammasonics, Inc. | 1984-08-09 |
| K832737 | ECT PROCESSOR | Siemens Gammasonics, Inc. | 1983-09-29 |
| K812966 | 400T ECT SOFTWARE | General Electric Co. | 1981-11-24 |
| K810873 | STAR | Intl. General Electric Co. | 1981-04-23 |
| K801917 | STAR | General Electric Co. | 1980-09-16 |
| K780368 | MODUMED MUGX | Medtronic Vascular | 1978-03-14 |
Legacy Summary#
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FDA Review#
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