Capintec, Inc.
Capintec, Inc. holds FDA 510(k) medical device clearances, first cleared 1978, most recent 2019, with 4 FDA device recalls on record.
Top product codes for Capintec, Inc.
FDA recalls by Capintec, Inc.
- Z-1564-2020 — Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
- Z-0550-2019 — Captus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077
- Z-0551-2019 — Captus 700 Thyroid Uptake System, Model # 5430-3137 and 5430-3138
- Z-2312-2012 — Capintec Captus 3000 Thyroid Uptake System Nuclear uptake probe intended to be used by trained Nuclear Medicine Technologists to perform thyroid uptake procedures, which consist of the measurement of organ uptake and circulating radioactivity.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Capintec, Inc.
- K192199 — CRC PC Smart Chamber K1
- K162394 — CRC-77tHR
- K141413 — CRC PC WITH SMART CHAMBER
- K101452 — CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TW
- K071396 — CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS
- K052595 — CRC 15ULTRA
- K030175 — 2 BASIC
- K020150 — CRC-15BT
- K982448 — CARDIOLIGHT
- K980402 — CAPINTEC MODEL 292 ELECTROMETER
- K946387 — CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER
- K853737 — VEST(AMBULATORY VENTRICULAR EVALUATING SYSTEM)
- K823240 — CAP-RIA 16
- K780157 — RADIATION TREATMENT PLANNING SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.