← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

JAQSystem, Applicator, Radionuclide, Remote-Controlled

DEVICE CLASS
Class II
REGULATION
21 CFR 892.5700
MEDICAL SPECIALTY
Radiology
REVIEW PANEL
RA
ImplantLife-sustainingGMP-exemptThird-party review eligible
11
510(K)/PMA CLEARANCES
510k: 11
0
RECALL ENTRIES

Recent clearances

K252717Varian Medical Systems · 510k2026-05-20
K251037Nucletron B.V. · 510k2025-12-19
K252884Varian Medical Systems · 510k2025-11-19
K250299Varian Medical Systems, Inc. · 510k2025-05-09
K250289Varian Medical Systems · 510k2025-04-25
K243939Varian Medical Systems, Inc. · 510k2025-03-03
K241764Varian Medical Systems, Inc. · 510k2025-01-10
K242961Varian Medical Systems · 510k2024-11-26

Related on SPEQ

Medical devices industryMedical device quality (ISO 13485)FDA device clearancesFDA enforcement & recalls

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →