# K981678: Strata, Model V.O.95

- Pathway: 510(k) (Traditional)
- Applicant: Rosses Medical Systems
- Decided: Dec 11, 1998 after 213 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- 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 FDA summary names its predicate without a number.
- (no number) Prowess 2000 (SSGI, Inc.): named in the summary without a submission number
- (no number) Therpac PLUS B3D TUI (Multimedia Medical Systems, Inc.): named in the summary without a submission number

## Indications for use
The proposed Strata system must be used by a qualified clinical staff member (generally a Medical Physicist or Dosimetrist), the results should then be approved by a licensed Radiation Oncologist. The proposed Strata device is intended to assist the clinician in determining optimal placement of Low Dose Rate radioisotopes about a lesion or tumor (benign or malignant) seated in human tissue. The information gathered in this planning system is used for localization, visualization of regional interest, calculating dose of implanted radioisotopes, and finally out putting data in hardcopy form (printer/plotter). Strata is not intended to prescribe dose, invade the patient or control hardware which can directly harm the patient.

Source page: https://510kreport.com/device/K981678
Methodology: https://510kreport.com/methodology