# K043278: Teratech Model 8IOC4, 8IOL4 & 10LAP4 Probes

- Pathway: 510(k) (Traditional)
- Applicant: Teratech Corp.
- Decided: Dec 13, 2004 after 17 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
23 later devices descend from it; 4 cite it directly.
0 of 24 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) Philips L19-5: named in the summary without a submission number
- (no number) Teratech 10V5: named in the summary without a submission number
- (no number) Philips C8-4: named in the summary without a submission number
- (no number) Philips LAP L9-5: named in the summary without a submission number

## Most influential descendants
- K050347: Modification to Cryocare CS Surgical System (2005), 12 descendants of its own
- K060279: Cryocare CS Surgical System (2006), 9 descendants of its own
- K101333: Cryocare CS Surgical System (2010), 8 descendants of its own
- K141110: Cryocare CS Surgical System (2015), 7 descendants of its own
- K061153: Gynesonics EC6 Transducer (2006), 7 descendants of its own

## Indications for use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: specific indications for use are tabulated in Section 4.3 of this submission.

Source page: https://510kreport.com/device/K043278
Methodology: https://510kreport.com/methodology