# K090296: Atomlab 400 and Atomlab 500 Dose Calibrators, Models 086-330, -331, -332, -335 and -336

- Pathway: 510(k) (Traditional)
- Applicant: Biodex Medical Systems, Inc.
- Decided: Feb 19, 2009 after 13 days
- Product code: KPT (Calibrator, Dose, Radionuclide)
- Device class: 2
- Regulation: 21 CFR 892.1360
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K884312 (1989). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K884312: Atomlab 100, Model 086-250 & 200 Model 086-270, Atomic Products Corp. (1989) Summary page 1.
- K071396: CRC 25 Series (CRC 25R, CRC 25PET, CRC 25W) Dose Calibrators, Capintec, Inc. (2007) Summary page 1.

## Recalls of this device
- Aug 16, 2021 · Class II · Z-2580-2021: When deleting a previously entered custom isotope, the software deletes the isotope, but not the associated dial setting. Possible other stored custom isotopes may then have incorrect dial settings an
- Aug 16, 2021 · Class II · Z-2581-2021: When deleting a previously entered custom isotope, the software deletes the isotope, but not the associated dial setting. Possible other stored custom isotopes may then have incorrect dial settings an

## Indications for use
The Atomlab dose calibrators are used in Nuclear Medicine Departments, clinics and nuclear pharmacies for calibrating radioactive doses for administration to patients. The instrument is used to verify the radioactivity of a radionuclide before administration to the patient.

Source page: https://510kreport.com/device/K090296
Methodology: https://510kreport.com/methodology