Photoelectric Therapy System— 510(k) K172080
Substantially EquivalentXstrahl, Ltd.
FDA 510(k) clearance K172080 for Photoelectric Therapy System, Substantially Equivalent on 2017-09-29. Applicant: Xstrahl, Ltd.. Device class: 2.
Clearance details
- Applicant
- Xstrahl, Ltd.
- Product code
- Code JAD
- Device class
- Class 2
- Regulation
- 21 CFR 892.5900
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brownhills, GB
Recent devices under product code JAD
view allMore clearances from Xstrahl, Ltd.
view allRecalls naming K172080
K-number listed on FDA's recall record- Z-1404-2022 — X80 RADiant Photoelectric Therapy System
- Z-0174-2022 — Concerto User Interface Software provided with the following systems: (1) Xstrahl 100 Electronic Brachytherapy - 100kV Superficial X-Ray Therapy System; (2) Xstrahl 150 Electronic Brachytherapy - 150kV Superficial X-Ray Therapy System; (3) Xstrahl 200 - 225kV Superficial / Orthovoltage X-Ray Therapy System; (4) Xstrahl 300 - 300kV Orthovoltage X-Ray Therapy System; (5) Xstrahl X 80 Photoelectric Therapy System.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K172080.
Data sourced from openFDA. This site is unofficial and independent of the FDA.