# K001210: HI-Res 9000 Phased Array Carotid Coil

- Pathway: 510(k) (Traditional)
- Applicant: Usa Instruments, Inc.
- Decided: Jun 9, 2000 after 56 days
- Product code: MOS (Coil, Magnetic Resonance, Specialty)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
242 later devices descend from it; 3 cite it directly.
19 of 243 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K012491: Machnet Carotids Coil Array Assembly (2001), 229 descendants of its own
- K083166: Specialty Coils for the Magnetom Essenza (2009), 222 descendants of its own
- K103275: Specialty Coils for Magnetom Aera 1.5T & Magnetim Skyra 3T MR Systems (2011), 221 descendants of its own
- K111242: Magnetom Aera and Magnetom Skyra (2011), 220 descendants of its own
- K121434: Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio (2012), 215 descendants of its own

Source page: https://510kreport.com/device/K001210
Methodology: https://510kreport.com/methodology