← Product Code [NHA](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA) · K231072
# Anthogyr FlexiBase® titanium bases for Axiom® BL (K231072)
_Anthogyr · NHA · Jan 4, 2024 · Dental · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA/K231072
## Device Facts
- **Applicant:** Anthogyr
- **Product Code:** [NHA](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA.md)
- **Decision Date:** Jan 4, 2024
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3630
- **Device Class:** Class 2
- **Review Panel:** Dental
- **Attributes:** Therapeutic
## Indications for Use
FlexiBase® titanium bases for Axiom® BL are intended to support screw-retained restorations on Axiom® BL dental implants.
## Device Story
Anthogyr FlexiBase® titanium bases are two-piece dental abutments for Axiom® BL implants; used to support single-unit customized prosthetic restorations. Device consists of a titanium alloy base, a prosthetic screw (DLC-coated titanium alloy), and a patient-specific coping/crown. Clinicians design restorations using Straumann CARES® Visual software; digital designs are sent to a validated Straumann milling center for fabrication. The titanium base is screwed into the implant; the coping/crown is cemented onto the base using dental cement (e.g., PANAVIA V5). The final assembly is screwed into the patient's implant. Used in dental clinics by dentists/prosthodontists. Benefits include customized prosthetic support for single-tooth replacement. Device is provided non-sterile; requires end-user steam sterilization.
## Clinical Evidence
No clinical data. Evidence consists of bench testing, including dynamic fatigue testing (ISO 14801) in saline at 37°C for 2 million cycles (permanent) and 200,000 cycles (temporary) without failure. Biocompatibility was evaluated per ISO 10993-1 and ISO 10993-5. Sterilization was validated per ISO 17665-1/2.
## Technological Characteristics
Materials: Titanium alloy (3.7165.1-Ti-6Al-4VELI). Dimensions: 4.0mm/5.0mm platform diameters; 1.5mm/2.5mm/3.5mm gingival heights. Energy: Mechanical (screw-retained). Connectivity: Digital workflow via Straumann CARES System. Sterilization: Non-sterile, requires autoclave. Software: CAD/CAM design software.
## Regulatory Identification
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.
## Special Controls
*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)
## Predicate Devices
- Medentika CAD/CAM Abutments ([K150203](/device/K150203.md))
## Reference Devices
- Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia Discs ([K222836](/device/K222836.md))
- Straumann BLX Variobase Abutment ([K190082](/device/K190082.md))
- Straumann BLX Implant System ([K173961](/device/K173961.md))
- Straumann® Variobase® Abutments ([K170354](/device/K170354.md))
- Axiom PX ([K161177](/device/K161177.md))
- Axiom Reg ([K131066](/device/K131066.md))
- Anthofit Ol, Anthofit HE, Ossfit, and Axiom ([K101913](/device/K101913.md))
## Submission Summary (Full Text)
> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "U.S. Food & Drug Administration" in blue.
January 4, 2024
Anthogyr % Jennifer Jackson Sr. Dir, Regulatory & Quality NAM Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01801
Re: K231072
Trade/Device Name: Anthogyr FlexiBase® titanium bases for Axiom® BL Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: December 5, 2023 Received: December 5, 2023
#### Dear Jennifer Jackson:
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.
{1}------------------------------------------------
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 System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (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.
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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
{2}------------------------------------------------
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
# Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
#### Indications for Use
510(k) Number (if known) K231072
Device Name
Anthogyr FlexiBase® titanium bases for Axiom® BL
Indications for Use (Describe)
Anthogyr FlexiBase® titanium bases for Axiom® BL are indicated for use as a support for single-unit customized prosthetic restorations. All digitally designed copings and / or crowns for use with the Anthogyr Flexibase® titanium bases for Axiom® BL are intended to be sent to Straumann for manufacturing by a validated milling center (Straumann CARES System).
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|--------------------------------------------------------------------------------------|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
### K231072 - Anthogyr FlexiBase® titanium bases for Axiom® BL
### 510(k) Summary
#### Submitter's Contact Information
| Submitter: | Straumann USA, LLC (on behalf of Anthogyr)
60 Minuteman Road
Andover, MA 01810
Registration No.: 1222315 Owner/Operator No.: 9005052 |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| | On the behalf of: |
| | Anthogyr
2 237 Avenue André Lasquin
74700 Sallanches, France |
| Contact Person: | Jennifer M. Jackson, MS, RAC
Sr. Director, Regulatory Affairs and Quality
Phone Number: +1 978 747-2509
Fax Number: +1 978 747-0023 |
| Prepared By &
Alternate Contact: | Estelle SALLE
Regulatory Affairs Project Manager
Anthogyr
Phone number: +33 (0)4 50 58 02 37 |
| Date of Submission: | January 4, 2024 |
#### Name of the Device
| Trade Names: | Anthogyr FlexiBase® titanium bases for Axiom® BL |
|------------------------|------------------------------------------------------|
| Common Name: | Endosseous dental implant abutment (21 CFR 872.3630) |
| Classification Name: | Endosseous dental implant abutment (21 CFR 872.3630) |
| Regulation Number: | §872.3630 |
| Device Classification: | II |
| Product Code(s): | NHA |
| Classification Panel: | Dental |
{5}------------------------------------------------
### K231072 - Anthogyr FlexiBase® titanium bases for Axiom® BL
#### Predicate Device(s)
Primary Predicate:
- K150203 Medentika CAD/CAM Abutments .
Reference Devices:
- K222836 Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia Discs .
- K190082 Straumann BLX Variobase Abutment .
- . K173961 – Straumann BLX Implant System
- K170354 Straumann® Variobase® Abutments .
Compatible Dental Implants:
- K161177 Axiom PX .
- K131066 Axiom Reg .
- K101913 Anthofit Ol, Anthofit HE, Ossfit, and Axiom .
#### Device Description
#### Anthogyr FlexiBase® titanium bases for Axiom® BL
Anthogyr FlexiBase® titanium bases for Axiom® BL are intended to be placed into Anthogyr dental implants to provide support for single-unit restorations. The second component of the two-piece abutment (coping or crown) must be cemented onto the titanium component of the FlexiBase® abutment to constitute the final two-piece abutment design, which is then screwed onto the implant.
The bottom portion of the FlexiBase® are made from Titanium alloy. They are provided in several dimensions, there is one chimney height, and two platform diameters of 4.0 mm and 5.0 mm, and for each of the platform diameters there are three gingival heights of 1.5 mm, 2.5 mm and 3.5 mm.
Anthogyr FlexiBase® titanium bases for Axiom® BL are very similar to the primary predicate device Medentika TiBase CAD/CAM Abutments cleared in K150203.
The FlexiBase® are fixed in the implant by means of a prosthetic screw which is manufactured in titanium alloy and DLC coated identical to K161177.
{6}------------------------------------------------
### K231072 - Anthogyr FlexiBase® titanium bases for Axiom® BL
The FlexiBase® abutments are two-piece abutments used as a base when fabricating a CAD/CAM customized restoration. The design and milling of the customized restoration must be made using the Straumann CARES® Visual software.
The FlexiBase® is a two-piece abutment ultimately composed by three components:
- . FlexiBase® abutment titanium component
- Top-half component (coping and/or crown) .
- . Prosthetic screw
The FlexiBase® abutments will be marketed:
- through a validated Straumann Centralized milling center, in this case all digitally . designed copings and/or crowns are intended to be manufactured at a validated Straumann milling center (Straumann CARES® System).
#### Prosthetic Restoration Design and Materials
The following is an overview of the possible coping materials:
- n!ce CoCr .
- n!ce Zr LT
- . n!ce Zr HT
- . n!ce Zr XT
- . n!ce glass ceramic
- . n!ce PMMA (temporary)
The design of the digital coping and/or crown should follow the standard procedure according to the material manufacturer's instructions for use and Anthogyr's instructions for use.
#### Anthogyr prosthetic screw
A prosthetic screw is used to fix abutments to dental implants. The screw is provided with the abutments and also available standalone (replacement).
The prosthetic screws are manufactured from titanium alloy and are DLC coated identical to K161177.
#### Intended Use
FlexiBase® titanium bases for Axiom® BL are intended to support screw-retained restorations on Axiom® BL dental implants.
{7}------------------------------------------------
### K231072 - Anthogyr FlexiBase® titanium bases for Axiom® BL
#### Indications for Use
Anthogyr FlexiBase® titanium bases for Axiom® BL are indicated for use as a support for singleunit customized prosthetic restorations. All digitally designed copings and / or crowns for use with the Anthogyr Flexibase® titanium bases for Axiom® BL are intended to be sent to Straumann for manufacturing by a validated milling center (Straumann CARES System).
#### Technological Characteristics
The technological characteristics of the subject devices are compared to the primary predicate and reference devices in the following tables:
{8}------------------------------------------------
## K231072 - Anthogyr FlexiBase® titanium bases for Axiom® BL
| | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | | |
|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FEATURE | Subject Device - Anthogyr
FlexiBase® titanium bases
for Axiom® BL | Medentika CAD/CAM Abutments
K150203 | Straumann BLX Variobase
Abutment
K190082 | Straumann BLX Implant
System
K173961 | Straumann® Variobase®
Abutments
K170354 |
| Indication for
use | Anthogyr FlexiBase®
titanium bases for Axiom®
BL are indicated for use as
a support for single-unit
customized prosthetic
restorations. All digitally
designed copings and / or
crowns for use with the
Anthogyr Flexibase®
titanium bases for Axiom®
BL are intended to be sent
to Straumann for
manufacturing by a
validated milling center
(Straumann CARES
System). | Medentika CAD/CAM abutments are
intended for use with dental implants
as a support for single or multiple
tooth prostheses in the maxilla or
mandible of a partially or fully
edentulous patient.
Abutments are compatible with the
following implant systems:
E-Series: Nobel Biocare Replace™
Select 3.5, 4.3, 5.0, 6.0 F-Series: Nobel Biocare
NobelActive™ 3.5, 4.3, 5.0 H-Series: Biomet 3i Osseotite Certain
3.25, 4.0, 5.0 I-Series: Biomet 3i Osseotite 3.25,
3.75, 4.0, 5.0 K-Series: Nobel Biocare Brånemark
3.3, 3.75, 4.0, 5.0 L-Series: Straumann Bone Level 3.3,
4.1, 4.8 N-Series: Straumann Standard 3.3,
4.1, 4.8 R-Series: Zimmer Tapered Screw-
Vent 3.3, 3.7, 4.1, 4.7, 6.0 S-Series: Astra Tech OsseoSpeed
3.5/4.0, 4.5/5.0 T-Series: Dentsply Friadent
Frialit/XiVE 3.4, 3.8, 4.5, 5.5 Y-Series: Dentsply Friadent Ankylos
3.5, 4.5, 5.5, 7.0 Medentika TiBase is intended for use
with the Straumann® CARES® System. | Straumann® Variobase®
prosthetic components directly
or indirectly connected to the
endosseous dental implant
are intended for use as an aid
in prosthetic rehabilitations.
The prosthetic restoration
(crowns) can be cemented
onto the Straumann®
Variobase®
prosthetic components. A
temporary restoration can be
used prior to the insertion of
the final components to
maintain, stabilize and shape
the soft tissue during the
healing phase; they must be
placed out of occlusion. Final
abutments and restorations
may be placed into occlusion
when the implant is fully
osseointegrated. All digitally
designed copings and/or
crowns for use with the
Straumann® Variobase®
Abutment system are
intended to be sent to
Straumann for manufacture at
a validated milling center. | Straumann® Variobase®
prosthetic components directly
or indirectly connected to the
endosseous dental implant are
intended for use as an aid in
prosthetic rehabilitations.
The prosthetic restoration
(crowns) can be cemented onto
the Straumann® Variobase®
prosthetic components. A
temporary restoration can be
used prior to the insertion of the
final components to maintain,
stabilize and shape the soft
tissue during the healing phase;
they must be placed out of
occlusion. Final abutments and
restorations may be placed into
occlusion when the implant is
fully osseointegrated. All digitally
designed copings and/or crowns
for use with the Straumann®
Variobase® Abutment system
are intended to be sent to
Straumann for manufacture at a
validated milling center. | The Straumann®
Variobase™ Abutment is
a titanium base placed
onto Straumann dental
implants to provide
support for customized
prosthetic restorations.
Straumann® Variobase™
Abutments are indicated
for screw-retained single
tooth or cement retained
single tooth and bridge
restorations. |
| Material | Titanium: 3.7165.1-Ti-6Al-
4VELI | Titanium Alloy: Ti-6Al-4V ELI | Ti-6Al-7Nb | Ti-6Al-7Nb | Titanium-Aluminum-
Niobium alloy (Ti-6Al-
7Nb) |
| Abutment
diameters | Ø4 mm and Ø5 mm | Ø 3.0 - 7.0 mm | Ø 3.8 to 5.5 mm | Ø 3.8, 4.5, and 5.5 mm | Ø 3.8 - 7.0 mm |
| | PROPOSED DEVICE
PRIMARY PREDICATE DEVICE
REFERENCE DEVICE | | | | |
| FEATURE | Subject Device - Anthogyr
FlexiBase® titanium bases
for Axiom® BL | Medentika CAD/CAM Abutments
K150203 | Straumann BLX Variobase
Abutment
K190082 | Straumann BLX Implant
System
K173961 | Straumann® Variobase®
Abutments
K170354 |
| Titanium
component
Gingival
height(s)* | 1.5, 2.5 and 3.5 mm* | - | 0.75 - 3.5 mm* | 0.75 - 2.5 mm* | - |
| Titanium
component
chimney
height(s)* | 3.5 mm* | 4 mm - 5.5 mm* | 4 mm and 6 mm* | - | 3.5 – 4.5 mm* |
| Minimum
Abutment
Post Height
above the
gingival
margin of the
final design | 4 mm | 4 mm | 4 mm | 4 mm | 4 mm |
| Restoration
type | Single-unit | Single or multiple tooth
prostheses | Screw-retained single-unit, or
Cement-retained single or
multi-unit | - | - |
| Top-half
materials | n!ce CoCr
n!ce Zr LT
n!ce Zr HT
n!ce Zr XT
n!ce® glass ceramic
n!ce PMMA (temporary) | Zirconia | coron®
zerion® LT
zerion® ML and UTML | IPS e.max CAD
Polycon® ae | Coron®
Zerion®
IPS e.max CAD
n!ce
Polycon® ae |
| Abutment
angulation | Up to 30° | Up to 30° | Up to 30° | Up to 30° | Up to 30° |
| Prosthesis
attachment | Screw-retained | Cement retained | Cement retained | Screw-retained or cement
retained | Screw-retained or
cement retained |
| Cement used
in device
performance
testing | PANAVIA V5 by KURARAY
DENTAL, cleared by FDA
under K150704 | Multilink Hybrid Abutment
Cement by Ivoclar (K130436). | Kuraray Panavia V5 | Kuraray Panavia V5 | - |
| | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | | |
| FEATURE | Subject Device - Anthogyr
FlexiBase® titanium bases
for Axiom® BL | Medentika CAD/CAM Abutments
K150203 | Straumann BLX Variobase
Abutment
K190082 | Straumann BLX Implant
System
K173961 | Straumann® Variobase®
Abutments
K170354 |
| Cement to fix
patient-
specific
coping
according to
IFU | PANAVIA V5 by KURARAY
DENTAL, cleared by FDA
under K150704 | Multilink Hybrid Abutment
Cement by Ivoclar (K130436). | Kuraray Panavia V5 | Kuraray Panavia V5…
---
**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA/K231072](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA/K231072)
**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).
**Cite:** Innolitics at https://innolitics.com