Icon Computer System
FDA 510(k) K914350 · Siemens Gammasonics, Inc.
510(k) numberK914350
Submission
- Device name
- Icon Computer System
- Applicant
- Siemens Gammasonics, Inc.
Hoffman Estates, IL, US - Received
- September 27, 1991
- Decision date
- November 22, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code JWM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K851687 | Jumbo Digital Gammacamera GCA-90BJWM · Traditional | Toshiba Medical Systems | 06/05/1985SE |
| 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 |
|---|---|---|
| K934766 | Carbon Fiber PalletIYX · Traditional | 02/18/1994SE |
| K933664 | Polytron T.O.P. (Time, Operation, Performance)IZI · Traditional | 12/15/1993SE |
| K933256 | Fan Beam CollimatorIYX · Traditional | 10/29/1993SE |
| K920319 | Sienet Image Display Workstations, Image AcquisitiLLZ · Traditional | 10/20/1992SE |
| K923582 | Sienet Camera ServerLMD · Traditional | 10/14/1992SE |
| K922373 | Multispect(Tm) 2 Dual Detector Camera SystemKPS · Traditional | 08/17/1992SE |
| K922372 | Multispect(Tm) 3 Triple Detector Camera SystemKPS · Traditional | 08/17/1992SE |
| K920310 | Sienet Archive Server, Isa I, Isa II Storage ServeLMD · Traditional | 03/30/1992SE |
| K920309 | Sienet Diagnostic Reporting ConsoleLLZ · Traditional | 03/20/1992SE |
| K914313 | HicorIZI · Traditional | 11/27/1991SE |
Questions and answers
When was Icon Computer System cleared by the FDA?
Icon Computer System (K914350) received a 510(k) decision of Substantially Equivalent on November 22, 1991, 56 days after the submission was received.
What is the product code of K914350?
The FDA product code is JWM – System, Tomographic, Nuclear, a Class II (moderate risk) device regulated under 21 CFR 892.1310.