# K050190: Apollo

- Pathway: 510(k) (Abbreviated)
- Applicant: Villa Sistemi Medicali S.P.A.
- Decided: Mar 25, 2005 after 57 days
- Product code: KXJ (Table, Radiologic)
- Device class: 2
- Regulation: 21 CFR 892.1980
- Recalls of this device: 15 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K030046: Philips Medical Systems OMNIDIAGNOST ELEVA. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Recalls of this device
- Nov 4, 2019 · Class II · Z-0765-2020: An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was found that due to met
- Nov 4, 2019 · Class II · Z-0766-2020: An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was found that due to met
- Nov 4, 2019 · Class II · Z-0764-2020: An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was found that due to met
- Nov 4, 2019 · Class II · Z-0763-2020: An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was found that due to met
- Dec 27, 2016 · Class II · Z-1430-2017: Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving from vertical position.
- Dec 27, 2016 · Class II · Z-1429-2017: Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving from vertical position.
- Dec 27, 2016 · Class II · Z-1427-2017: Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving from vertical position.
- Dec 27, 2016 · Class II · Z-1428-2017: Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving from vertical position.
- Feb 19, 2016 · Class II · Z-1063-2017: The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a prohibited area 
- Feb 19, 2016 · Class II · Z-1064-2017: The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a prohibited area 
- Feb 19, 2016 · Class II · Z-1065-2017: The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a prohibited area 
- Feb 19, 2016 · Class II · Z-1066-2017: The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a prohibited area 
- Dec 14, 2014 · Class II · Z-1079-2015: The system does not provide the appropriate audible signal, permanent activation, and manual override, although the system is in high-level control functionality
- Aug 2, 2013 · Class II · Z-2160-2013: It has been discovered that the Air Kerma rate information is inconsistent in Continuous Fluoro modes 30x30 (12"x12") and 15x15 (6"x6). This could result in a deviation of the displayed values of Air 
- Dec 13, 2012 · Class II · Z-0702-2013: Values of fluoroscopy time, Air Kerma Rate and Cumulated Air Kerma may not be displayed "at the fluoroscopist's working position" as per 21 CFR 1003.21

## Indications for use
The indication for use of the APOLLO is: radiology and fluoroscopy investigations when installed in conjunction with adequate image intensifier, image acquisition systems, X-ray generators and X-ray tubes.

Source page: https://510kreport.com/device/K050190
Methodology: https://510kreport.com/methodology