# K984398: Liquichek Ana Control, Homogeneous Pattern, Model 201

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Dec 18, 1998 after 9 days
- Product code: DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control)
- Device class: 2
- Regulation: 21 CFR 866.5100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K905070 (1991). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954276: Stealthstation, Surgical Navigation Technologies, Inc. (1996) Summary page 1.
- K961844: Operating Arm System (Oas) [with CT and MR Images], Radionics Software Applications, Inc. (1996) Summary page 1.
- K970604: Viewpoint - 3.0 Software, Philips Medical Systems (Cleveland), Inc. (1997) Summary page 1.
- K861692: Fischer PPS/Mammotest Mammography System, Fischer Imaging Corp. (1986) Summary page 1.

## Indications for use
The Fluorotactic Guidance System Mk. I will be used to assist in the accurate placement of a guiding device for surgery in which a lincar trajectory insertion or placcment is required. This system will use coordinated-fluoroscopy to allow intra-operative planning of the precise insertion point and angle of a device such as a screw, nail, or needle, The surgeon will place a registration artifact over the desired surgical area and capture two fluoroscopic images, which will then be displayed on two computer screens. The surgeon will manipulate a virtual guidewire on the screens, until the desired angle and placement is achieved. The system will then output 3D coordinates to the robot arm which will mave the drill gnide to a precise position.

Source page: https://510kreport.com/device/K984398
Methodology: https://510kreport.com/methodology