Jumbo Digital Gammacamera GCA-90B
FDA 510(k) K851687 · Toshiba Medical Systems
510(k) numberK851687
Submission
- Device name
- Jumbo Digital Gammacamera GCA-90B
- Applicant
- Toshiba Medical Systems
Tustin, CA, US - Received
- April 23, 1985
- Decision date
- June 5, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code JWM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K914350 | Icon Computer SystemJWM · Traditional | Siemens Gammasonics, Inc. | 11/22/1991SE |
| K904599 | D2 Spectrum Gamma Camera/Crystal V Computer SystemJWM · Traditional | Digital Design, Inc. | 04/23/1991SE |
| K903315 | IconJWM · Traditional | Siemens Gammasonics, Inc. | 01/09/1991SE |
| K901545 | GCA-9300 Nuclear Tomography SystemJWM · Traditional | Toshiba America Medical Systems, In.C | 06/26/1990SE |
| K874473 | Adac Model Arc-St, PC Style Data Processing SystemJWM · Traditional | Adac Laboratories | 07/18/1988SE |
| K873075 | Adac Model ARC-5000, Gamma CameraJWM · Traditional | Adac Laboratories | 10/30/1987SE |
| K851685 | Digital Gamma Camera Gca 601 EJWM · Traditional | Toshiba Medical Systems | 06/14/1985SE |
| K850885 | Starcam Data Acquisition & Processing Sys H3300CJWM · Traditional | General Electric Co. | 06/06/1985SE |
| K851686 | Digital Gamma Camera Gca 501SJWM · Traditional | Toshiba Medical Systems | 06/05/1985SE |
| K841905 | Dot-A, Dot-Ar Pxp-E, Pxp-ErJWM · Traditional | Siemens Gammasonics, Inc. | 08/09/1984SE |
More from Siemens Gammasonics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K960948 | Scatter Correction Volume Software Model NSSC-020AKPS · Traditional | 12/23/1996SE |
| K954310 | BLA-800AKPW · Traditional | 10/18/1995SE |
| K954309 | AngiorexIZI · Traditional | 10/06/1995SE |
| K893750 | MRT-50A MobileLNH · Traditional | 08/09/1989SE |
| K891453 | Diagnostic Ultrasound Transducer: PVE-582VIYO · Traditional | 06/01/1989SE |
| K890969 | Transesophageal Transducer PEF-511SAIYO · Traditional | 05/16/1989SE |
| K884788 | Toshiba TCT-600XT Computed Tomography X-Ray SystemJAK · Traditional | 02/27/1989SE |
| K884555 | TCT-600HQ Compu Tomo(Ct)Xray/Head/Whole Body ExamJAK · Traditional | 02/27/1989SE |
| K883359 | Diagnostic Ultrasound System SSA-270AIYO · Traditional | 01/25/1989SE |
| K883756 | Toshiba MRT-50A Magnetic Resonance SystemLNH · Traditional | 11/14/1988SE |
Questions and answers
When was Jumbo Digital Gammacamera GCA-90B cleared by the FDA?
Jumbo Digital Gammacamera GCA-90B (K851687) received a 510(k) decision of Substantially Equivalent on June 5, 1985, 43 days after the submission was received.
What is the product code of K851687?
The FDA product code is JWM – System, Tomographic, Nuclear, a Class II (moderate risk) device regulated under 21 CFR 892.1310.