Atomlab Dose Calibrator

FDA UDI

Class II (US FDA UDI)

by Biodex Medical Systems

Identity

Trade Name: Atomlab Dose Calibrator FDA UDI
Generic Name: Radioisotope calibration system FDA UDI
Device Name: Atomlab 400 Dose Calibrator FDA UDI
Model / Reference: 086-335 FDA UDI
Description: Atomlab 400 Dose Calibrator FDA UDI

Identifiers

Catalog Number: 086-335 FDA UDI
Primary DI / UDI-DI: 00718175003350 FDA UDI
510(k) Number: K090296 FDA UDI
FDA Product Code: KPT FDA UDI
GMDN Term: Radioisotope calibration system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1360 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Radioisotope calibration system

Atomlab Dose Calibrator by Biodex Medical Systems — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radioisotope calibration system.

IBC-Lite — Comecer Netherlands B.V. · Class II
VDC606 — Comecer Netherlands B.V. · Class II
Capintec Dose Calibrator — MIRION TECHNOLOGIES (CAPINTEC), INC · Class II
Capintec Dose Calibrator — MIRION TECHNOLOGIES (CAPINTEC), INC · Class II
Capintec Dose Calibrator — MIRION TECHNOLOGIES (CAPINTEC), INC · Class II
Atomlab 500 Dose Calibrator — Biodex Medical Systems · Class II
Atomlab Wipe Test Counter — Biodex Medical Systems · Class II
Atomlab 500 Plus — Biodex Medical Systems · Class II

Cleared under the same submission

K090296 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Biodex Medical Systems

Sources (1)

FDA UDI 8c1c60cc-df78-48a8-b9f3-2483a5b45227 35 fields · synced Jun 8, 2026