# K912470: Philips Diagnost 96

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems, Inc.
- Decided: Aug 7, 1991 after 64 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
138 later devices descend from it; 3 cite it directly.
0 of 139 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
- K960266: Siregraph CF (1996), 132 descendants of its own
- K970734: Siregragh T.O.P. 33 and Siregraph T.O.P. 40 Universal Fluoroscopic X-Ray Systems (1997), 131 descendants of its own
- K992660: Urf Digital - OT (1999), 130 descendants of its own
- K062623: Axiom Luminos DRF (2007), 78 descendants of its own
- K040675: Axiom Artis U (2004), 49 descendants of its own

## Recalls of this device
- Apr 18, 2011 · Not classified · Z-2765-2011: Updated Instructions For Use: During an examination where the patient is positioned on a -rotatable- chair with knees pointed to the rear of the system, the patients lower legs or ankles may be injure
- Oct 10, 2003 · Not classified · Z-0097-04: The thumbscrew hinge pin on the monitor support arm could become loose allowing the monitor to fall.
- Aug 10, 2003 · Not classified · Z-1212-03: Potential for table to move by itself
- Aug 10, 2003 · Not classified · Z-1214-03: Potential for table to move by itself
- Aug 10, 2003 · Not classified · Z-1213-03: Potential for table to move by itself
- Jul 17, 2003 · Not classified · Z-1242-03: Labeling of push button caps located on the control panel may not clearly identify the applied Source to Image distance (SID).
- Feb 20, 2002 · Not classified · Z-1204-03: Spontaneous movement of table without input from an operator
- Feb 20, 2002 · Not classified · Z-1203-03: Spontaneous movement of table without input from an operator
- Feb 20, 2002 · Not classified · Z-1205-03: Spontaneous movement of table without input from an operator

Source page: https://510kreport.com/device/K912470
Methodology: https://510kreport.com/methodology