# K961105: Skin Dose Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Mcmahon Medical
- Decided: Sep 5, 1996 after 169 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) In Vivo Dosimeter: named in the summary without a submission number

## Most influential descendants
- K042698: Unfors Patient Skin Dosimeter (PSD) (2004), 0 descendants of its own

## Indications for use
Although intended primarily for use during Radiological Interventional and Special Procedures, the Skin Dose Monitor can be used whenever there is an interest in knowing patient skin‘dose. The primary purpose of the product is to monitor beam entry skin dose within the radiation beam, where there may be a risk of skin burns or cancers du~ to extremely high doses. In these situations the beam direction is fixed for a major part of the procedure and the sensor siting is obvious. If the Skin Dose Monitor is to be used for other applications such as dose monitoring of a pregnant woman during general radiological procedures or monitoring doses during fluoroscopic guided surgery, the sensor site may be less obvious. Under these circumstances the sensor might be mounted on the X-Ray collimator face. The real time display of dose may be used to indicate the need to take action to avoid excessive dose to one area of skin by changing the beam direction. The rate indicating LED provides a means to take action which will keep dosage per minute during fluoroscopy at the minimum level needed to ensure acceptable images. The Skin Dose Monitor is also an effective tool for use during staff training or when benchmark protocols are being established for new procedures. Contra indications for use are when the radiation energy or doserate being used fall outside the Skin Dose Monitor's specification, or where the small artefact ¢ "he image (1 sq. mm), due to the sensor, is unacceptable. ‘. attention is drawn to the user for the need to gas sterilize sensors between applications in accordance with local infection control practice.

Source page: https://510kreport.com/device/K961105
Methodology: https://510kreport.com/methodology