FORTE— 510(k) K982911
Substantially EquivalentAdac Laboratories
FDA 510(k) clearance K982911 for FORTE, Substantially Equivalent on 1998-11-16. 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 K982911
K-number listed on FDA's recall record- Z-0213-2020 — 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-0216-2020 — 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-1774-2015 — FORTE (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 K982911.
Data sourced from openFDA. This site is unofficial and independent of the FDA.