# K972192: Perception Inc. GPS-Xyz Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Perception, Inc.
- Decided: Dec 17, 1997 after 190 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K905198 (1991). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925486: Ust-5522-7.5 & Ust-5522L-7.5 Intraoperative Trans., Aloka Co., Ltd. (1993) Summary page 1.
- K920374: Aloka 650CL Diagnostic Ultrasound System, Ge Medical Systems Information Technologies (1992) Summary page 1.
- K905198: Diagnostic Ultrasound System Type 3535, Bruel & Kjaer (1991) Summary page 1.
- K914945: Diagnostic Ultrasound System Type 3535, Modified, Bruel & Kjaer Industri A/S (1992). Our OCR of the scanned summary read K914925, FDA’s number for Medac System/3 (Davicon, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Bruel and Kjaer Diagnostic Ultrasound Type 3535 System and Transducers”.
- K945796: Sharplan Usight 9010 Laparoscopic Ultrasound System, Sharplan Lasers, Inc. (1995) Summary page 1.
- (no number) International Ultrasound Systems Inc., Model AU-530: named in the summary without a submission number

## Most influential descendants
- K981834: Perception Inc, GPS-6TBMD Diagnostic Ultrasound System (1998), 0 descendants of its own

## Indications for use
The GPS-XYZ device is a diagnostic ultrasound system which produces two-dimensional diagnostic ultrasonic images. The following intended uses are identified for the transducer applications: General Radiology, Abdominal, Cardiac and Vascular, with the use of ultrasonic probes from 2.8-12.5 MHz. There is no transcranial application for this device.

Source page: https://510kreport.com/device/K972192
Methodology: https://510kreport.com/methodology