DARPAC 2000 SUPERFICIAL X-RAY THERAPY SYSTEM— 510(k) K962613
Substantially EquivalentGulmay Medical , Ltd.
FDA 510(k) clearance K962613 for DARPAC 2000 SUPERFICIAL X-RAY THERAPY SYSTEM, Substantially Equivalent on 1996-09-27. Applicant: Gulmay Medical , Ltd.. Device class: 2.
Clearance details
- Applicant
- Gulmay Medical , 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
- Shepperton, Middlesex, GB
Recent devices under product code JAD
view allRecalls naming K962613
K-number listed on FDA's recall record- Z-0389-2022 — Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray 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 K962613.
Data sourced from openFDA. This site is unofficial and independent of the FDA.