FORTE GAMMA CAMERA SYSTEM— 510(k) K033254
Substantially EquivalentAdac Laboratories
FDA 510(k) clearance K033254 for FORTE GAMMA CAMERA SYSTEM, Substantially Equivalent on 2003-10-22. Applicant: Adac Laboratories. Device class: 2.
Clearance details
- Applicant
- Adac Laboratories
- Product code
- Code KPS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1200
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Milpitas, CA, US
Recent devices under product code KPS
view allMore clearances from Adac Laboratories
view allRecalls naming K033254
K-number listed on FDA's recall record- Z-0214-2020 — Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.
- Z-0215-2020 — Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.
- Z-0217-2020 — Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.
- Z-1777-2015 — Forte-JetStream AZ (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K033254.
Data sourced from openFDA. This site is unofficial and independent of the FDA.