3D-RD-S

K262060 · Radiopharmaceutical Imaging & Dosimetry, LLC · LLZ · Sep 4, 2026 · Radiology

Device Facts

• Record ID: K262060
• Device Name: 3D-RD-S
• Applicant: Radiopharmaceutical Imaging & Dosimetry, LLC
• Product Code: LLZ · Radiology
• Decision Date: Sep 4, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Indications for Use

3D-RD-S is intended to estimate radiation absorbed dose (and related quantities) to tissues after administration of a radioactive product. For use with internally administered radioactive products, 3D-RD-S should not be used to deviate from product dosing and administration instructions. Refer to the product's prescribing information for instructions.

Device Story

3D-RD-S is a cloud-based SaMD for internal radiation dosimetry. It utilizes MIRD methodology and S-value-based approaches to estimate absorbed dose. The subject device adds 3D-RD-Si, an optional imaging module that imports NM and CT datasets; supports image registration; and provides segmentation tools to derive quantitative dosimetry inputs. Users review, modify, and confirm all segmentations before the system processes them through the established dosimetry engine. The device is used by clinicians to support clinical decision-making regarding radioactive product administration. It does not replace prescribing information. Benefits include standardized, quantitative dosimetry estimates based on patient-specific imaging data.

Clinical Evidence

No clinical data. Bench testing evaluated the consistency of dosimetric outputs (activity quantification, TAC generation, TIAC calculation, absorbed dose) between the new imaging-derived input workflow and the established 3D-RD-S workflow. All comparisons met the <10% difference acceptance criterion, with average differences <5% and a maximum difference of 6.74%.

Technological Characteristics

Cloud-based SaMD. Performs internal dosimetry using MIRD methodology and S-value-based approaches. Imaging functionality (3D-RD-Si) supports NM and CT data import, registration, and user-reviewed segmentation. Software-only; no physical materials. Verification and validation conducted per design controls.

Indications for Use

Indicated for estimating radiation absorbed dose to tissues following administration of radioactive products in neonates, infants, children, adolescents, and adults.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• Voxel Dosimetry (K243919)

Reference Devices

• 3D-RD-S (K212587)

Submission Summary (Full Text)

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**FDA** U.S. FOOD & DRUG
ADMINISTRATION

September 4, 2026

Radiopharmaceutical Imaging & Dosimetry, LLC
Nadine Bonds
Director of Quality Assurance / Regulatory Affairs
1800 Gough St.
Baltimore, Maryland 21231

Re: K262060

Trade/Device Name: 3D-RD-S

Regulation Number: 21 CFR 892.2050

Regulation Name: Medical Image Management And Processing System

Regulatory Class: Class II

Product Code: LLZ

Dated: June 18, 2026

Received: June 18, 2026

Dear Nadine Bonds:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

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K262060 - Nadine Bonds

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Daniel M. Krainak, Ph.D.
Assistant Director
DHT8C: Division of Radiological
Imaging and Radiation Therapy Devices
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K262060 | ? |
| Please provide the device trade name(s). | | ? |
| 3D-RD-S | | |
| Please provide your Indications for Use below. | | ? |
| 3D-RD-S is intended to estimate radiation absorbed dose (and related quantities) to tissues after administration of a radioactive product. For use with internally administered radioactive products, 3D-RD-S should not be used to deviate from product dosing and administration instructions. Refer to the product's prescribing information for instructions. | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
| Please select the age group(s) for which the device(s) is to be used. | ☑ Neonates/Newborns (Birth to < 29 days old) ☑ Infants (29 days old to < 2 years old) ☑ Children (2 years old to < 12 years old) ☑ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ? |

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K262060


# 510(k) Summary

### 1. Submitter Information

Radiopharmaceutical Imaging & Dosimetry, LLC

1800 Gough St.

Baltimore, MD, 21231

Phone: [phone], Ext. 105

Email Address: [e-mail]

Contact Person: Nadine Bonds, Director of Quality Assurance / Regulatory Affairs

Date Prepared: July 8, 2026

### 2. Device Name

Trade Name: 3D-RD-S

Common Name: 3D-RD-S

Classification Name: Medical Image Management and Processing System

### 3. Regulation and Classification

Regulation Number: 892.2050

Product Code: LLZ

Device Class: Class II

### 4. Predicate Device

Trade Name: Voxel Dosimetry

Manufacturer: Hermes Medical Solutions AB

510(k) number: K243919

Radiopharmaceutical Imaging & Dosimetry, LLC

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## 5. Device Description

3D-RD-S is a cloud-based Software as a Medical Device (SaMD) intended to estimate radiation absorbed dose and related quantities following administration of a radioactive product. The software performs internal dosimetry calculations using established Medical Internal Radiation Dose (MIRD) methodology and S-value-based approaches. The dosimetry engine, calculations, intended use, and outputs remain unchanged from the previously cleared 3D-RD-S device (K212587).

The subject device includes an optional imaging-based functionality, referred to as 3D-RD-Si, which enables users to derive quantitative dosimetry input information from nuclear medicine (NM) and computed tomography (CT) imaging datasets. Imaging functionality includes image import, image display, registration support, segmentation tools, and quantitative image analysis. The system may provide an initial segmentation to assist the user in defining volumes of interest (VOIs); however, all segmentations are reviewed by the user, modified as needed, and must be explicitly confirmed prior to use within the dosimetry workflow.

The optional imaging functionality provides an alternative method for generating quantitative dosimetry input information used within the established 3D-RD-S workflow. The functionality does not modify the dosimetry calculations, methodology, intended use, or outputs of the previously cleared device. All absorbed dose calculations continue to be performed using the established 3D-RD-S dosimetry engine.

## 6. Indications for Use

3D-RD-S is intended to estimate radiation absorbed dose (and related quantities) to tissues after administration of a radioactive product. For use with internally administered radioactive products, 3D-RD-S should not be used to deviate from product dosing and administration instructions. Refer to the product's prescribing information for instructions.

## 7. Technological Characteristics

The subject device and predicate device are software-only medical devices intended to support absorbed dose estimation following administration of radioactive products. The primary technological characteristics are summarized below.

Comparison Summary

| Characteristic | 3D-RD-S with 3D-RD-Si | Hermes Voxel Dosimetry (K243919) |
| --- | --- | --- |
| Device Type | Software as a Medical Device | Software as a Medical Device |
| Imaging Inputs | NM and CT imaging datasets | PET/SPECT and CT imaging datasets |
| Image Registration | Supports image registration as part of the imaging workflow | Supports rigid and non-rigid image registration |

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| Characteristic | 3D-RD-S with 3D-RD-Si | Hermes Voxel Dosimetry (K243919) |
| --- | --- | --- |
| Segmentation | Supports user-reviewed segmentation workflows | Supports semi-automatic organ and lesion segmentation with user review |
| Quantitative Analysis | Derives quantitative dosimetry input information from imaging data | Generates quantitative information from image analysis workflows |
| Dosimetry Methodology | Existing 3D-RD-S dosimetry engine using established MIRD methodology | Voxel-based absorbed dose calculation methodology |
| User Review | User review, modification as needed, and confirmation of segmentation results are required prior to use in dosimetry calculations | User review and correction are required prior to the use of semi-automatic segmentation for dosimetry calculations |
| Outputs | Absorbed dose estimates and related quantities | Absorbed dose information and dose distribution results |

# Summary of Technological Differences

- The subject device includes an imaging-based functionality (3D-RD-Si) that derives quantitative dosimetry input information from NM and CT imaging data for use within the established 3D-RD-S workflow.
- The previously cleared 3D-RD-S dosimetry calculations, methodology, intended use, and outputs remain unchanged.
- Differences between the devices relate primarily to software architecture, workflow implementation, and image-processing approach and do not raise different questions of safety or effectiveness.

### 8. Performance Testing

# Software Verification and Validation

Software verification and validation activities were conducted in accordance with established design control procedures and a risk-based software development process. Testing included unit testing, integration testing, system testing, workflow validation, and regression testing. All testing met predefined acceptance criteria.

# Non-Clinical Performance Testing

Benchmark testing was conducted to evaluate whether imaging-derived input functionality within 3D-RD-Si produces dosimetric outputs consistent with those generated using the previously cleared 3D-RD-S workflow. Testing used aligned NM and CT imaging datasets, predefined segmentation inputs,

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and analyst-directed workflows while holding segmentation inputs constant to isolate the effect of imaging-derived input processing.

Testing evaluated:

- Activity quantification
- Time-activity curve (TAC) generation
- Time-integrated activity coefficient (TIAC) calculation
- Absorbed dose calculation performance

All evaluated comparisons met the predefined acceptance criterion of less than 10% difference. Observed average differences across evaluated datasets were below 5%, with the maximum observed difference being 6.74%, which remained within acceptance criteria. Results demonstrated that outputs generated using imaging-derived inputs were consistent with outputs generated using the established 3D-RD-S workflow.

# Clinical Testing

Clinical testing was not required to support substantial equivalence.

# 9. Conclusion

3D-RD-S with the optional imaging-based functionality (3D-RD-Si) and Hermes Voxel Dosimetry (K243919) are software-only medical devices that support absorbed dose estimation through the use of imaging-derived quantitative information and dosimetry calculations. Both devices utilize image processing, segmentation, quantitative image analysis, and user-reviewed workflows to support the generation of information used in absorbed dose estimation.

The optional 3D-RD-Si functionality provides an alternative method for deriving quantitative dosimetry input information from NM and CT imaging datasets while maintaining the previously cleared 3D-RD-S dosimetry methodology, calculations, intended use, and outputs. Verification, validation, and benchmark testing demonstrated that the device performs as intended and that imaging-derived inputs produce results consistent with the previously cleared workflow. Therefore, 3D-RD-S with the optional 3D-RD-Si functionality is substantially equivalent to Hermes Voxel Dosimetry (K243919) and does not raise new or different questions of safety or effectiveness.

Radiopharmaceutical Imaging & Dosimetry, LLC

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