# K142597: Vienna System

- Pathway: 510(k) (Traditional)
- Applicant: Mick Radio-Nuclear Instruments, Inc.
- Decided: Feb 19, 2015 after 157 days
- Product code: JAQ (System, Applicator, Radionuclide, Remote-Controlled)
- Device class: 2
- Regulation: 21 CFR 892.5700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K864210 (1986). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030110: CT HDR Tandem/Ring Applicator with Rectal Retractor, Mick Radio-Nuclear Instruments, Inc. (2003) Summary page 5.
- K122840: CT HDR Tandem/Ring Applicator with Rectal Retractor Model 0407, Mick Radio-Nuclear Instruments, Inc. (2012) Summary page 5.
- K080934: Vienna Ring CT/MR Applicator Set, Round Point Titanium Needle Set, Trocar Point Titanium Needle Set, Nucletron Corporation (2008) Summary page 5.

## Indications for use
The Mick Radio-Nuclear Instruments, Inc. Vienna System is intended to be used as an accessory to the Mick CT HDR Tandem I Ring Applicator and is indicated for High Dose Rate irradiation of the uterus and cervix. The Vienna System consists of perforated Build-Up Caps and complementary Needle Collectors which connect to the Mick CT HDR Tandem I Ring Applicator. Pre-bent interstitial needles are intended to be used with the Vienna System but they are not manufactured by Mick Radio-Nuclear Instruments, Inc. and are not part of this submission. Build-Up Caps When used with the CT HDR Tandem/Ring Applicator, the Vienna Build-Up Caps enable the introduction of up to nine (9) interstitial needles around the circumference of the ring to enhance the standard HDR treatment. The Vienna System is not designed to be used with any Rectal Retractor due to the introduction of the interstitial needles. Needle Collectors When used in conjunction with the Vienna Build-Up Caps, the Needle Collectors will maintain and control the positioning of an array of up to nine (9) interstitial needles. The Needle Collectors are part of the Vienna System and as such, are not designed to be used with any Rectal Retractor. The Vienna System is designed to be used as an accessory with the Applicator and this does not alter the indications for use.

Source page: https://510kreport.com/device/K142597
Methodology: https://510kreport.com/methodology