# K981993: Olympus Integrated Endosurgery System Endoalpha

- Pathway: 510(k) (Traditional)
- Applicant: The Olympus Optical Co.
- Decided: Aug 21, 1998 after 74 days
- Product code: ODA (Endoscopic Central Control Unit)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K801623 (1980). 23 ancestors in all.
175 later devices descend from it; 5 cite it directly.
4 of 199 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970184: Olympus Ues-20 Electrosurgical System and Its Associated Accessories, Olympus America, Inc. (1997) Summary page 2.
- K972114: Olympus Sonosurg System, The Olympus Optical Co. (1998) Summary page 2.
- K953163: Quick Read 2000 (QR2000), Quicksilver Systems, Inc. (1995) Summary page 2.
- K963184: Olympus Subcutaneous Endoscopy System, Olympus America, Inc. (1996) Summary page 2.
- K971416: Olympus Oes Otv-S5C Video System, Olympus America, Inc. (1997) Summary page 2.
- K944017: Olympus Laparoscopic Ultrasound System, Olympus America, Inc. (1995) Summary page 2.
- K943304: 3D Surgical Endoscopy System for Urology, Olympus America, Inc. (1995) Summary page 2.
- K943305: Olympus 3D Surgical Endoscopy System, Olympus America, Inc. (1995) Summary page 2.
- K943307: 3D Surgical Endoscopy System for General Surgery, Olympus America, Inc. (1995) Summary page 2.

## Most influential descendants
- K994231: Siemens Integrated Operating System (Sios) (2000), 157 descendants of its own
- K052202: Axiom Artis - Modular Angiographic System (2006), 154 descendants of its own
- K061054: Axiom Aristos FX Plus (2006), 80 descendants of its own
- K062623: Axiom Luminos DRF (2007), 78 descendants of its own
- K073290: Artis Zee and Zeego (2008), 72 descendants of its own

## Indications for use
The Olympus Integrated Endosurgery System EndoALPHA has been designed to be used with an Olympus endoscope ancillary equipment for central operation, central display, automatic initial setting and interlocking operation of the ancillary equipment.

Source page: https://510kreport.com/device/K981993
Methodology: https://510kreport.com/methodology