# K981834: Perception Inc, GPS-6TBMD Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Perception, Inc.
- Decided: Sep 29, 1998 after 126 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K921750 (1992). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963616: Aloka SSD-1700 Diagnostic Ultrasound System, Aloka Co., Ltd. (1997). Our OCR of the scanned summary read K063616, FDA’s number for Trident II Acetabular System (Howmedica Osteonics Corp.), decided Dec 20, 2006, after this device. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Aloka Co. Model SSD-1700”.
- K935024: ESI-5000, Elscint, Inc. (1996) Summary page 1.
- K924079: CFM-800 Color Flow Mapping System, Diasonics, Inc. (1993) Summary page 1.
- K962662: Vingmed Sound Color Flow Mapping System, Diasonics, Inc. (1997) Summary page 1.
- K972973: Perception Inc. GPS-Tuv Diagnostic Ultrasound System, Perception, Inc. (1997) Summary page 1.
- K972192: Perception Inc. GPS-Xyz Diagnostic Ultrasound System, Perception, Inc. (1997) Summary page 1.
- K900469: Ultrasound Scanner Model #1150, Pie Medical USA BV (1990) Summary page 1.
- K961229: HR12000 Ultrasound System, International Ultrasound Corp. (1997) Summary page 1.

## Indications for use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K981834
Methodology: https://510kreport.com/methodology