Volume Computation Software Package
FDA 510(k) K890638 · Elscint, Inc.
510(k) numberK890638
Submission
- Device name
- Volume Computation Software Package
- Applicant
- Elscint, Inc.
Hackensack, NJ, US - Received
- February 8, 1989
- Decision date
- August 7, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JOP – Transducer, Ultrasonic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2880
- Specialty
- Cardiovascular
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| K242662 | Falcon/Xpress (Falcon/Xpress)JOP · Traditional | Viasonix , Ltd. | 12/18/2024SE |
| K233976 | VasoGuard (V10, V8, V6, V4, V2)JOP · Traditional | Corvascular Diagnostics, LLC | 07/19/2024SE |
| K153762 | Smartdop XT6JOP · Traditional | Koven Technology, Inc. | 05/25/2016SE |
| K131623 | Smartdop XTJOP · Traditional | Koven Technology, Inc. | 01/17/2014SE |
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| K111416 | FalconJOP · Traditional | Viasonix , Ltd. | 07/15/2011SE |
| K071730 | Studiodop VicorderJOP · Abbreviated | Skidmore Medical, Limited | 12/20/2007SE |
| K010482 | Echoflow Portable Doppler Blood Flow Measurement System; Model PEF-1JOP · Special | Echocath, Inc. | 03/20/2001SE |
| K002766 | Nicolet VasoguardJOP · Abbreviated | Nicolet Biomedical | 11/30/2000SE |
| K990642 | Echoflow Doppler Blood Velocity MeterJOP · Traditional | Echocath, Inc. | 09/16/1999SE |
More from Echocath, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K983313 | Advanced Automatic Detector Selection Option for GloryIZH · Traditional | 12/11/1998SE |
| K982060 | Volumax CT Imaging SystemJAK · Traditional | 09/02/1998SE |
| K974344 | CT ScopeJAK · Traditional | 06/03/1998SE |
| K980306 | Gyrex 2T Prestige, Gyrex Prima Itg, Gyrex Privilege, Gyrex V-EpLNH · Traditional | 04/02/1998SE |
| K974614 | Gyrex 2T Prestige 100-6321-0107, Gyrex Priviledge 100-6326-0102, Gyrex Prima 1TG…LNH · Traditional | 03/04/1998SE |
| K972592 | 2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101)MOS · Traditional | 09/15/1997SE |
| K970680 | GloryIZH · Traditional | 06/20/1997SE |
| K965044 | Gyrex 2T Prestige Model No. 100-6321-0107 and Gyrex Privilege Model No. 100-6326-0102LNH · Traditional | 06/16/1997SE |
| K970980 | Cardiac Scoring for CT ScannersJAK · Traditional | 05/29/1997SE |
| K970005 | Gyrex 2T-PRESTIGELNI · Traditional | 03/28/1997SE |
Questions and answers
When was Volume Computation Software Package cleared by the FDA?
Volume Computation Software Package (K890638) received a 510(k) decision of Substantially Equivalent on August 7, 1989, 180 days after the submission was received.
What is the product code of K890638?
The FDA product code is JOP – Transducer, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 870.2880.