# K974199: Acute Cardiac Ischemia Time-Insensitive Predictive Instrument (Aci-Tipi) Option

- Pathway: 510(k) (Traditional)
- Applicant: Marquette Medical Systems, Inc.
- Decided: Feb 6, 1998 after 88 days
- Product code: LOS
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
72 later devices descend from it; 1 cites it directly.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Hewlett-Packard Model 1791A ACI-TIPI: named in the summary without a submission number

## Most influential descendants
- K014108: Mac 5000 Ecg Analysis System (2002), 71 descendants of its own
- K091513: Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B, SE-6, SE-600, SE-12, SE-12 Express and SE-1200 (2009), 32 descendants of its own
- K033492: Modification to Mac 5000 Ecg Analysis System (2003), 31 descendants of its own
- K042177: Modification to Mac 5000 Ecg Analysis System (2004), 30 descendants of its own
- K060833: 12SL Ecg Analysis Program (2006), 21 descendants of its own

## Indications for use
Acute Cardiac Ischemia Time-Insensitive Predictive Instrument (ACI-TIPI) Option is intended to be used in a hospital or clinic environment by competent health professionals. ACI-TIPI utilizes recorded ECG data along with patient demographic and chest pain status to produce a numerical score which is the predicted probability of acute cardiac ischemia. Like any computer-assisted ECG interpretation program, the Marquette ACI-TIPI evaluation and probability score is intended to supplement, not substitue for the physician’s decision process. It should be used in conjunction with knowledge of the patient's history, the results of a physical examination, the ECG tracing, and other clinical findings. ACI-TIPI is intended for adult patient populations.

Source page: https://510kreport.com/device/K974199
Methodology: https://510kreport.com/methodology