Calypso System
Basic Information
- Brand Name
- Calypso System
- Primary DI
- 00850011006115
- Version / Model
- 3
- Catalog Number
- ASM0195
- Company Name
- VARIAN MEDICAL SYSTEMS, INC.
- Labeler DUNS
- 070809675
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-06-07
- Public Version
- 4
- Public Version Date
- 2021-08-24
- Public Version Status
- Update
- Public Device Record Key
- f2b8e722-ed79-4dd8-b8bb-b345f65b146e
Device Description
The Calypso System utilizes non-ionizing electromagnetic and optical technology to provide accurate, objective, and continuous localization of a treatment target for patient alignment and target position monitoring during radiation therapy. Use of the Calypso System for target localization is based on the system’s detection of electromagnetic signals from passive implanted markers, called Beacon transponders. The Beacon transponders are placed on the patient’s skin surface or implanted in or near the treatment target. When used with the Calypso System, the Beacon transponder signals enable objective, continuous measurement of the localization of the treatment target in 3 dimensions. The system operator uses this information for patient alignment and continuous target positioning (i.e., tracking) during radiation therapy treatment.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IYE | Accelerator, Linear, Medical | Radiology | 892.5050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46467 | Radiation therapy invasive marker lesion localization system | An assembly of noninvasive devices intended to monitor the position of a patient's tumour/lesion relative to the isocenter of a radiation therapy system, to assist with their alignment during treatment planning or a therapeutic procedure. It localizes the position of invasive markers [e.g., electromagnetic (EM) signal transmitters, radiopaque markers] (not included) which have been introduced/implanted in or near the target site prior to treatment. It typically includes an EM receiver and dedicated software. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850011006115 | GS1 |
Customer Contacts
- Phone
- +1(888)827-4265
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K123137 | 000 |