# K925302: Philips Integris H/HM System

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems, Inc.
- Decided: Dec 17, 1992 after 57 days
- Product code: IZF (System, X-Ray, Tomographic)
- Device class: 2
- Regulation: 21 CFR 892.1740
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
46 later devices descend from it; 1 cites it directly.
5 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K982203: Caas II Lva Biplane Option (1998), 45 descendants of its own
- K033920: Caas II Rva (2004), 44 descendants of its own
- K052988: CAAS (2005), 43 descendants of its own
- K063344: Caas Qca 3D (2006), 39 descendants of its own
- K072591: Cardiop-B System, Version 2.1 (2007), 38 descendants of its own

## Recalls of this device
- Jul 16, 2018 · Class II · Z-3237-2018: There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceilin
- Jul 16, 2018 · Class II · Z-3238-2018: There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceilin
- Jul 16, 2018 · Class II · Z-3239-2018: There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceilin
- Oct 12, 2005 · Not classified · Z-0206-06: Potential for high voltage exposure involving the injector interface connector of patient support tables.
- Oct 12, 2005 · Not classified · Z-0207-06: Potential for high voltage exposure involving the injector interface connector of patient support tables.

Source page: https://510kreport.com/device/K925302
Methodology: https://510kreport.com/methodology